Trial Outcomes & Findings for Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001 (NCT NCT02868229)

Results Overview

The MTD assessment was based on safety data. If more than 2 of 8 active participants in a cohort experience a Dose-Limiting Toxicities (DLT), the MTD was considered to have been exceeded. The DLT threshold was defined using a threshold of greater than or equal to (\>=) Grade 3 events, which includes severe: infusion-related reactions, cardiopulmonary infusion reactions, anaphylaxis, or hypersensitivity. DLTs are defined as follows: 1. Confirmed Grade 3 neutropenia and representing a decline of \> 25% from baseline 2. Serious adverse events (SAEs) of infection in the presence of confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia. 3. ≥ Grade 3 ALT (Alanine transaminase) or AST(Aspartate transaminase) 4. ≥ Grade 4 hematologic toxicity 5. ≥ Grade 3 non-hematologic toxicity

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

61 participants

Primary outcome timeframe

Weeks 0-24

Results posted on

2021-07-30

Participant Flow

The trial was conducted at 13 sites in the United States.

Participants were randomized to ziltivekimab (COR-001) or placebo within each cohort. For the first and other higher dose cohorts, first 2 participants were randomized 1:1 to ziltivekimab or placebo, and were treated at least 48 hours prior to the remaining participants randomized in a 7:1 ratio of ziltivekimab to placebo. For cohorts with doses less than the maximum tolerated dose (MTD) determined from earlier cohorts, randomization was done in 8:2 ratio of ziltivekimab to placebo.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on Erythropoiesis stimulating agents (ESA) and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Overall Study STARTED	12	16	16	17
Overall Study Intent to Treat (ITT) Population	12	16	16	17
Overall Study Pharmacodynamic (PD) Population	12	16	13	12
Overall Study Pharmacokinetic (PK) Population	12	16	16	17
Overall Study Safety Analysis Population	12	16	16	17
Overall Study Maximum Tolerated Dose (MTD) Population	12	16	16	16
Overall Study COMPLETED	11	16	15	12
Overall Study NOT COMPLETED	1	0	1	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on Erythropoiesis stimulating agents (ESA) and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Overall Study Adverse Event	1	0	1
Overall Study Death	0	1	1
Overall Study Missed dose	0	0	3

Baseline Characteristics

Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on Erythropoiesis stimulating agents (ESA) and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=16 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=17 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	Total n=61 Participants Total of all reporting groups
Sex: Female, Male Male	9 Participants n=99 Participants	7 Participants n=107 Participants	8 Participants n=206 Participants	8 Participants n=7 Participants	32 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=99 Participants	7 Participants n=107 Participants	3 Participants n=206 Participants	4 Participants n=7 Participants	20 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=99 Participants	9 Participants n=107 Participants	13 Participants n=206 Participants	13 Participants n=7 Participants	41 Participants n=31 Participants
Age, Continuous	62.8 Years STANDARD_DEVIATION 10.23 • n=99 Participants	61.4 Years STANDARD_DEVIATION 12.95 • n=107 Participants	63.8 Years STANDARD_DEVIATION 10.98 • n=206 Participants	57.9 Years STANDARD_DEVIATION 10.56 • n=7 Participants	61.3 Years STANDARD_DEVIATION 11.24 • n=31 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	9 Participants n=107 Participants	8 Participants n=206 Participants	9 Participants n=7 Participants	29 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants	1 Participants n=7 Participants	4 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	5 Participants n=99 Participants	5 Participants n=107 Participants	10 Participants n=206 Participants	11 Participants n=7 Participants	31 Participants n=31 Participants
Race (NIH/OMB) White	7 Participants n=99 Participants	10 Participants n=107 Participants	4 Participants n=206 Participants	5 Participants n=7 Participants	26 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants

PRIMARY outcome

Timeframe: Weeks 0-24

Population: The MTD analysis population included all participants in the safety analysis population, which included all participants randomized and treated with any amount of study medication with exception of those replaced due to a non-safety reason.

The MTD assessment was based on safety data. If more than 2 of 8 active participants in a cohort experience a Dose-Limiting Toxicities (DLT), the MTD was considered to have been exceeded. The DLT threshold was defined using a threshold of greater than or equal to (\>=) Grade 3 events, which includes severe: infusion-related reactions, cardiopulmonary infusion reactions, anaphylaxis, or hypersensitivity. DLTs are defined as follows: 1. Confirmed Grade 3 neutropenia and representing a decline of \> 25% from baseline 2. Serious adverse events (SAEs) of infection in the presence of confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia. 3. ≥ Grade 3 ALT (Alanine transaminase) or AST(Aspartate transaminase) 4. ≥ Grade 4 hematologic toxicity 5. ≥ Grade 3 non-hematologic toxicity

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=16 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=17 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Characterization of Maximum Tolerated Dose (MTD) Infection SAEs with confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia.	0 Events	0 Events	0 Events	0 Events
Characterization of Maximum Tolerated Dose (MTD) >= Grade 3 ALT or AST	0 Events	0 Events	0 Events	0 Events
Characterization of Maximum Tolerated Dose (MTD) >= Grade 4 hematologic toxicity	0 Events	0 Events	0 Events	0 Events
Characterization of Maximum Tolerated Dose (MTD) >= Grade 3 non-hematologic toxicity	0 Events	0 Events	0 Events	0 Events
Characterization of Maximum Tolerated Dose (MTD) Confirmed Grade 3 neutropenia and representing a decline of > 25% from baseline	0 Events	0 Events	0 Events	0 Events

PRIMARY outcome

Timeframe: From baseline (mean of screening and day 1) to week 4

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from the baseline in hsCRP values to week 4 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=11 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=12 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in High-sensitivity C-reactive Protein (hsCRP): Week 4	0.373 Milligrams per liter (mg/L) Standard Deviation 3.765	-10.383 Milligrams per liter (mg/L) Standard Deviation 10.395	-11.981 Milligrams per liter (mg/L) Standard Deviation 8.232	-14.561 Milligrams per liter (mg/L) Standard Deviation 11.836

PRIMARY outcome

Timeframe: From baseline (mean of screening and day 1) to week 4

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from the baseline in serum amyloid A (SAA) values to week 4 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=10 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=10 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in Serum Amyloid A (SAA): Week 4	-3.733 mg/L Standard Deviation 6.955	-22.056 mg/L Standard Deviation 37.914	-9.878 mg/L Standard Deviation 6.687	-31.910 mg/L Standard Deviation 41.502

SECONDARY outcome

Timeframe: Weeks 0-24

Population: The safety analysis population included all participants randomized and treated with any amount of study medication.

Frequency of events of interest by treatment group and dose from baseline until the end of the safety follow-up period (week 24) were reported. Adverse events of special interest included severe infusion-related reactions, hypersensitivity reaction during study drug infusion, anaphylaxis and neutropenia events of grade 2 or higher (i.e., absolute neutrophil count \<1500/mm\^3 and decline by at least 25% from baseline).

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=16 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=17 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Number of Adverse Events of Special Interest	0 Events	0 Events	0 Events	0 Events

SECONDARY outcome

Timeframe: Week 0-24

Population: The safety analysis population included all participants randomized and treated with any amount of study medication.

An AE (adverse event) is any undesirable event or any untoward medical occurrence that occurs to a participant during the course of a study, or the protocol-defined time after study termination, whether or not that event is considered Study Drug-related. A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of study. Number of TEAEs from baseline until the end of safety follow up (week 24) were presented.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=16 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=17 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Number of Treatment Emergent Adverse Events (TEAEs)	33 Events	51 Events	83 Events	66 Events

SECONDARY outcome

Timeframe: At baseline, week 6, week 12, week 18 and week 24

Population: The safety analysis population included all participants randomized and treated with any amount of study medication.

A summary of the overall ECG interpretation and clinical significance from baseline until the end of the safety follow up period (week 24) is presented and categorized as Normal, Abnormal clinically significant (CS), Abnormal non clinically significant (NCS) and Missing.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=16 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=17 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Electrocardiogram (ECG) Week 6 · Abnormal, clinically significant (CS)	1 Participants	1 Participants	1 Participants	0 Participants
Electrocardiogram (ECG) Baseline · Normal	5 Participants	7 Participants	4 Participants	7 Participants
Electrocardiogram (ECG) Baseline · Abnormal, clinically significant (CS)	1 Participants	1 Participants	1 Participants	1 Participants
Electrocardiogram (ECG) Baseline · Abnormal, non clinically significant (NCS)	6 Participants	8 Participants	11 Participants	9 Participants
Electrocardiogram (ECG) Baseline · Missing	0 Participants	0 Participants	0 Participants	0 Participants
Electrocardiogram (ECG) Week 6 · Normal	6 Participants	3 Participants	4 Participants	4 Participants
Electrocardiogram (ECG) Week 6 · Abnormal, non clinically significant (NCS)	5 Participants	12 Participants	8 Participants	10 Participants
Electrocardiogram (ECG) Week 6 · Missing	0 Participants	0 Participants	3 Participants	3 Participants
Electrocardiogram (ECG) Week 12 · Normal	4 Participants	5 Participants	3 Participants	3 Participants
Electrocardiogram (ECG) Week 12 · Abnormal, clinically significant (CS)	1 Participants	1 Participants	2 Participants	1 Participants
Electrocardiogram (ECG) Week 12 · Abnormal, non clinically significant (NCS)	7 Participants	10 Participants	10 Participants	11 Participants
Electrocardiogram (ECG) Week 12 · Missing	0 Participants	0 Participants	1 Participants	2 Participants
Electrocardiogram (ECG) Week 18 · Normal	7 Participants	4 Participants	4 Participants	2 Participants
Electrocardiogram (ECG) Week 18 · Abnormal, clinically significant (CS)	1 Participants	1 Participants	0 Participants	0 Participants
Electrocardiogram (ECG) Week 18 · Abnormal, non clinically significant (NCS)	4 Participants	11 Participants	8 Participants	9 Participants
Electrocardiogram (ECG) Week 18 · Missing	0 Participants	0 Participants	4 Participants	6 Participants
Electrocardiogram (ECG) Week 24 · Normal	3 Participants	5 Participants	5 Participants	0 Participants
Electrocardiogram (ECG) Week 24 · Abnormal, clinically significant (CS)	1 Participants	1 Participants	0 Participants	1 Participants
Electrocardiogram (ECG) Week 24 · Abnormal, non clinically significant (NCS)	7 Participants	10 Participants	8 Participants	10 Participants
Electrocardiogram (ECG) Week 24 · Missing	1 Participants	0 Participants	3 Participants	6 Participants

SECONDARY outcome

Timeframe: Weeks 0-35

Population: The PK population included all participants who had any valid samples measured for study drug levels.

Number of participants who developed ADAs from baseline until the end of the extended follow up period (week 35) were reported. Samples with detectable ADAs were classified as positive for ADAs. Samples without detectable ADAs were classified as negative for ADAs.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=16 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=17 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Number of Participants Who Developed Anti-drug Antibodies (ADAs) Positive	2 Participants	2 Participants	1 Participants	4 Participants
Number of Participants Who Developed Anti-drug Antibodies (ADAs) Negative	10 Participants	14 Participants	15 Participants	13 Participants

SECONDARY outcome

Timeframe: Weeks 0-35

Population: The PK population included all participants who had any valid samples measured for study drug levels.

Number of participants with ADA titers for ADA-positive samples from baseline to week 35 is presented.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=16 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=17 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Number of Participants With ADA Titers	2 Participants	2 Participants	1 Participants	4 Participants

SECONDARY outcome

Timeframe: From baseline (mean of screening and week 1) to week 35

Population: The PK population included all participants who had any valid samples measured for study drug levels.

Number of participants with neutralizing ADAs from baseline to week 35 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=16 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=17 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Number of Participants With Neutralizing ADAs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline (mean of screening and day 1) to week 4

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in TSAT to week 4 is presented.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=15 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=12 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=12 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in Transferrin Saturation (TSAT): Week 4	0.467 Percentage of TSAT Standard Deviation 6.733	5.622 Percentage of TSAT Standard Deviation 12.942	1.806 Percentage of TSAT Standard Deviation 11.197	15.778 Percentage of TSAT Standard Deviation 12.384

SECONDARY outcome

Timeframe: From baseline (mean of screening and day 1), week 10, week 12

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in TSAT to the mean of weeks 10-12 is presented.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=13 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=12 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in TSAT: Mean of Weeks 10-12	2.278 Percentage of TSAT Standard Deviation 8.093	6.417 Percentage of TSAT Standard Deviation 7.157	9.167 Percentage of TSAT Standard Deviation 8.569	9.028 Percentage of TSAT Standard Deviation 6.121

SECONDARY outcome

Timeframe: From baseline (mean of screening and day 1) to week 4

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in CHr to week 4 is presented.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=13 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=11 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in Reticulocyte Hemoglobin (CHr): Week 4	-0.265 Picograms (pg) Standard Deviation 1.216	1.197 Picograms (pg) Standard Deviation 1.183	1.188 Picograms (pg) Standard Deviation 1.090	0.286 Picograms (pg) Standard Deviation 2.265

SECONDARY outcome

Timeframe: From baseline (mean of screening and day 1), week 10, week 12

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in hs-CRP to the mean of 10-12 weeks is presented.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=12 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=12 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in High Sensitivity C-reactive Protein (Hs-CRP): Mean of 10-12 Weeks	-0.021 mg/L Standard Deviation 0.293	-0.534 mg/L Standard Deviation 0.439	-0.916 mg/L Standard Deviation 0.337	-1.462 mg/L Standard Deviation 0.554

SECONDARY outcome

Timeframe: From baseline (mean of screening and day 1), week 10, week 12

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in SAA to the mean of weeks 10-12 is presented.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=13 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=12 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in SAA: Mean of Weeks 10-12	-1.262 mg/L Standard Deviation 19.056	-24.323 mg/L Standard Deviation 41.375	-8.688 mg/L Standard Deviation 6.665	-30.324 mg/L Standard Deviation 37.812

SECONDARY outcome

Timeframe: From baseline (mean of screening and day 1), week 10, week 12

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in serum pre-albumin to the mean of 10-12 weeks is presented.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=13 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=12 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in Serum Pre-albumin: Mean of 10-12 Weeks	0.273 Milligrams per decilitre (mg/dL) Standard Deviation 5.716	6.032 Milligrams per decilitre (mg/dL) Standard Deviation 6.989	8.571 Milligrams per decilitre (mg/dL) Standard Deviation 5.362	11.170 Milligrams per decilitre (mg/dL) Standard Deviation 4.983

SECONDARY outcome

Timeframe: From baseline (mean of screening and day 1) to week 12

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in albumin to week 12 is presented.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=13 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=11 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in Albumin: Week 12	0.042 Grams per decilitre (g/dL) Standard Deviation 0.288	0.122 Grams per decilitre (g/dL) Standard Deviation 0.212	0.192 Grams per decilitre (g/dL) Standard Deviation 0.151	0.336 Grams per decilitre (g/dL) Standard Deviation 0.192

SECONDARY outcome

Timeframe: From baseline (weekly mean of screening) to week 4

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in ERI to week 4 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=13 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=11 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in Erythropoietin Resistance Index (ERI): Week 4	-1.444 (Unit/kg/week) per (g/dL) Standard Deviation 3.590	-0.975 (Unit/kg/week) per (g/dL) Standard Deviation 1.716	-3.175 (Unit/kg/week) per (g/dL) Standard Deviation 4.761	-4.211 (Unit/kg/week) per (g/dL) Standard Deviation 5.785

SECONDARY outcome

Timeframe: From baseline (weekly mean of screening), week 8, week 12

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in ERI to the mean of weeks 8-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=13 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=12 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in ERI: Mean of Weeks 8-12	-2.714 (Units/kg/week) per (g/dL) Standard Deviation 10.546	-5.689 (Units/kg/week) per (g/dL) Standard Deviation 7.824	-7.842 (Units/kg/week) per (g/dL) Standard Deviation 8.231	-8.787 (Units/kg/week) per (g/dL) Standard Deviation 5.952

SECONDARY outcome

Timeframe: From baseline (weekly mean of screening), week 10, week 12

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in ERI to the mean of weeks 10-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=13 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=12 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in ERI: Mean of Weeks 10-12	-2.112 (Units/kg/week) per (g/dL) Standard Deviation 11.476	-6.477 (Units/kg/week) per (g/dL) Standard Deviation 8.756	-8.272 (Units/kg/week) per (g/dL) Standard Deviation 8.770	-8.690 (Units/kg/week) per (g/dL) Standard Deviation 6.005

SECONDARY outcome

Timeframe: From baseline (mean of screening and day 1), week 10, week 12

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in CHr to the mean of weeks 10-12 is presented.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=13 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=12 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in CHr: Mean of Weeks 10-12	-0.035 pg Standard Deviation 1.264	0.859 pg Standard Deviation 1.098	1.271 pg Standard Deviation 1.264	1.143 pg Standard Deviation 1.635

SECONDARY outcome

Timeframe: From baseline (mean of screening and day 1) to week 4

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in hemoglobin to week 4 is presented.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=13 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=11 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in Hemoglobin: Week 4	-0.043 g/dL Standard Deviation 1.416	0.473 g/dL Standard Deviation 0.751	0.805 g/dL Standard Deviation 0.957	0.973 g/dL Standard Deviation 0.720

SECONDARY outcome

Timeframe: From baseline (mean of screening and day 1), week 10, week 12

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in hemoglobin to weeks 10-12 is presented.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=13 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=12 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in Hemoglobin: Mean of Weeks 10-12	-0.107 g/dL Standard Deviation 1.756	0.848 g/dL Standard Deviation 1.156	0.963 g/dL Standard Deviation 1.131	0.772 g/dL Standard Deviation 1.236

SECONDARY outcome

Timeframe: From baseline (mean of screening and day 1), week 10, week 12

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in hemoglobin to weeks 10-12, excluding hemoglobin values following a change in the total weekly ESA (erythropoiesis stimulating agent) dose is presented. A change is defined as the first time when the ESA weekly dose goes up by \>25% or down by \>25% relative to the previous week's dose.

Outcome measures

Outcome measures
Measure	Placebo n=7 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=6 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=5 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=2 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in Hemoglobin: Mean of Weeks 10-12, Excluding Hemoglobin Values Following a Change in the Total Weekly ESA Dose	0.352 g/dL Standard Deviation 1.225	0.228 g/dL Standard Deviation 0.506	0.627 g/dL Standard Deviation 0.988	0.567 g/dL Standard Deviation 1.226

SECONDARY outcome

Timeframe: From baseline (weekly mean of screening) to week 12

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in ERI to week 12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=15 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=12 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=11 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in ERI: Week 12	-3.229 (Units/kg/week) per (g/dL) Standard Deviation 12.084	-6.381 (Units/kg/week) per (g/dL) Standard Deviation 8.956	-8.835 (Units/kg/week) per (g/dL) Standard Deviation 8.785	-8.690 (Units/kg/week) per (g/dL) Standard Deviation 6.356

SECONDARY outcome

Timeframe: From baseline (weekly mean of screening), week 9, week 12

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in ERI to the mean of weeks 9-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=13 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=12 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in ERI: Mean of Weeks 9-12	-2.320 (Units/kg/week) per (g/dL) Standard Deviation 11.392	-6.338 (Units/kg/week) per (g/dL) Standard Deviation 8.870	-8.293 (Units/kg/week) per (g/dL) Standard Deviation 8.780	-8.756 (Units/kg/week) per (g/dL) Standard Deviation 5.949

SECONDARY outcome

Timeframe: From baseline (mean of screening and day 1) to week 12

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in hemoglobin to week 12 is presented.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=15 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=12 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=11 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in Hemoglobin: Week 12	0.130 g/dL Standard Deviation 1.240	0.502 g/dL Standard Deviation 1.029	0.806 g/dL Standard Deviation 1.234	0.755 g/dL Standard Deviation 1.379

SECONDARY outcome

Timeframe: From baseline (mean of screening and day 1) to week 24

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change from baseline in hemoglobin to week 24 is presented.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 2 mg n=16 Participants Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 6 mg n=11 Participants Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.	COR-001 20 mg n=8 Participants Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
Change in Hemoglobin: Week 24	-0.803 g/dL Standard Deviation 1.929	0.154 g/dL Standard Deviation 1.083	-0.267 g/dL Standard Deviation 0.826	-0.079 g/dL Standard Deviation 0.703

SECONDARY outcome

Timeframe: From screening to week 4

Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Change in hemoglobin from screening to peak hemoglobin at week 4 is presented.