Trial Outcomes & Findings for Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease (NCT NCT01630889)
NCT ID: NCT01630889
Last Updated: 2021-10-01
Results Overview
Hb baseline was defined as the mean of the central laboratory Hb value from the baseline visit at Day 1 (prior to receiving the first dose of study drug in this study), plus any other central lab Hb values within 15 days prior to Day 1 regardless of fasting. The specific duration over which the participants were assessed was identified as "over time" for the endpoint in the study protocol. Therefore, to be consistent with the endpoint in the study protocol, an individual timepoint was not identified for this primary outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 252, 264, 288, 312, 336, 360, and 384
Results posted on
2021-10-01
Participant Flow
Participant milestones
| Measure |
Roxadustat
Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 grams (g)/deciliter (dL). However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining hemoglobin (Hb) then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
15
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Roxadustat
Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 grams (g)/deciliter (dL). However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining hemoglobin (Hb) then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Other than Specified
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Roxadustat
n=15 Participants
Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
|
|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 12.02 • n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 252, 264, 288, 312, 336, 360, and 384Population: Participants who received at least 1 dose of study drug.
Hb baseline was defined as the mean of the central laboratory Hb value from the baseline visit at Day 1 (prior to receiving the first dose of study drug in this study), plus any other central lab Hb values within 15 days prior to Day 1 regardless of fasting. The specific duration over which the participants were assessed was identified as "over time" for the endpoint in the study protocol. Therefore, to be consistent with the endpoint in the study protocol, an individual timepoint was not identified for this primary outcome measure.
Outcome measures
| Measure |
Roxadustat
n=15 Participants
Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
|
|---|---|
|
Change From Baseline in Hb Over Time
Baseline
|
10.05 g/dL
Standard Deviation 0.931
|
|
Change From Baseline in Hb Over Time
Change at Week 8
|
1.26 g/dL
Standard Deviation 0.633
|
|
Change From Baseline in Hb Over Time
Change at Week 24
|
1.58 g/dL
Standard Deviation 0.959
|
|
Change From Baseline in Hb Over Time
Change at Week 48
|
1.94 g/dL
Standard Deviation 1.324
|
|
Change From Baseline in Hb Over Time
Change at Week 72
|
2.54 g/dL
Standard Deviation 1.234
|
|
Change From Baseline in Hb Over Time
Change at Week 96
|
1.18 g/dL
Standard Deviation 1.141
|
|
Change From Baseline in Hb Over Time
Change at Week 120
|
1.61 g/dL
Standard Deviation 0.815
|
|
Change From Baseline in Hb Over Time
Change at Week 144
|
1.96 g/dL
Standard Deviation 0.804
|
|
Change From Baseline in Hb Over Time
Change at Week 168
|
1.40 g/dL
Standard Deviation 1.441
|
|
Change From Baseline in Hb Over Time
Change at Week 192
|
1.02 g/dL
Standard Deviation 1.063
|
|
Change From Baseline in Hb Over Time
Change at Week 216
|
1.34 g/dL
Standard Deviation 1.062
|
|
Change From Baseline in Hb Over Time
Change at Week 240
|
1.02 g/dL
Standard Deviation 0.779
|
|
Change From Baseline in Hb Over Time
Change at Week 264
|
1.63 g/dL
Standard Deviation 1.640
|
|
Change From Baseline in Hb Over Time
Change at Week 288
|
0.00 g/dL
Standard Deviation 1.647
|
|
Change From Baseline in Hb Over Time
Change at Week 312
|
0.23 g/dL
Standard Deviation 0.416
|
|
Change From Baseline in Hb Over Time
Change at Week 336
|
0.70 g/dL
Standard Deviation 0.000
|
|
Change From Baseline in Hb Over Time
Change at Week 360
|
-1.20 g/dL
Standard Deviation NA
NA=Standard Deviation cannot be calculated with N of 1.
|
|
Change From Baseline in Hb Over Time
Change at Week 384
|
-0.40 g/dL
Standard Deviation NA
NA=Standard Deviation cannot be calculated with N of 1.
|
SECONDARY outcome
Timeframe: Baseline up to Week 384Population: Participants who received at least 1 dose of study drug.
Hb baseline was defined as the mean of the central laboratory Hb value from the baseline visit at Day 1 (prior to receiving the first dose of study drug in this study), plus any other central lab Hb values within 15 days prior to Day 1 regardless of fasting.
Outcome measures
| Measure |
Roxadustat
n=15 Participants
Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
|
|---|---|
|
Number of Participants With Hb ≥10 g/dL
Baseline
|
9 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 8
|
13 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 24
|
13 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 48
|
13 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 72
|
11 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 96
|
7 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 120
|
8 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 144
|
7 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 168
|
5 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 192
|
5 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 216
|
5 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 240
|
5 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 264
|
4 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 288
|
3 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 312
|
3 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 336
|
2 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 360
|
1 Participants
|
|
Number of Participants With Hb ≥10 g/dL
Week 384
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 385Population: Participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Roxadustat
n=15 Participants
Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
|
|---|---|
|
Number of Participants Receiving Rescue Therapy (Composite of Blood Transfusions, Intravenous [IV] Iron, Erythropoiesis-Stimulating Agent [ESA])
Blood Transfusion
|
1 Participants
|
|
Number of Participants Receiving Rescue Therapy (Composite of Blood Transfusions, Intravenous [IV] Iron, Erythropoiesis-Stimulating Agent [ESA])
IV Iron
|
5 Participants
|
|
Number of Participants Receiving Rescue Therapy (Composite of Blood Transfusions, Intravenous [IV] Iron, Erythropoiesis-Stimulating Agent [ESA])
ESA
|
1 Participants
|
|
Number of Participants Receiving Rescue Therapy (Composite of Blood Transfusions, Intravenous [IV] Iron, Erythropoiesis-Stimulating Agent [ESA])
No Rescue Therapy
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 384Population: Participants who received at least 1 dose of study drug. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.
Weekly dose amount was the actual total dose amounts within a week, windowed by 7-day period from Day 1. The mean weekly dose is presented for selected time periods based on timepoints reported in Outcome Measures 1 and 2.
Outcome measures
| Measure |
Roxadustat
n=15 Participants
Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
|
|---|---|
|
Mean Weekly Dose of Study Drug Over Time
Week 1-4
|
257.0 mg
Standard Deviation 140.33
|
|
Mean Weekly Dose of Study Drug Over Time
Week 5 - 8
|
252.4 mg
Standard Deviation 115.26
|
|
Mean Weekly Dose of Study Drug Over Time
Week 21 - 24
|
282.3 mg
Standard Deviation 218.07
|
|
Mean Weekly Dose of Study Drug Over Time
Week 41 - 48
|
318.4 mg
Standard Deviation 216.90
|
|
Mean Weekly Dose of Study Drug Over Time
Week 61 - 72
|
236.7 mg
Standard Deviation 108.57
|
|
Mean Weekly Dose of Study Drug Over Time
Week 85 - 96
|
155.9 mg
Standard Deviation 114.27
|
|
Mean Weekly Dose of Study Drug Over Time
Week 109 - 120
|
142.8 mg
Standard Deviation 105.10
|
|
Mean Weekly Dose of Study Drug Over Time
Week 133 - 144
|
140.3 mg
Standard Deviation 101.03
|
|
Mean Weekly Dose of Study Drug Over Time
Week 157 - 168
|
152.2 mg
Standard Deviation 111.19
|
|
Mean Weekly Dose of Study Drug Over Time
Week 181 - 192
|
195.6 mg
Standard Deviation 184.77
|
|
Mean Weekly Dose of Study Drug Over Time
Week 205 - 216
|
209.4 mg
Standard Deviation 156.13
|
|
Mean Weekly Dose of Study Drug Over Time
Week 229 - 240
|
225.7 mg
Standard Deviation 164.58
|
|
Mean Weekly Dose of Study Drug Over Time
Week 253 - 264
|
327.9 mg
Standard Deviation 169.82
|
|
Mean Weekly Dose of Study Drug Over Time
Week 277 - 288
|
324.0 mg
Standard Deviation 190.75
|
|
Mean Weekly Dose of Study Drug Over Time
Week 301 - 312
|
319.2 mg
Standard Deviation 196.98
|
|
Mean Weekly Dose of Study Drug Over Time
Week 325 - 336
|
413.3 mg
Standard Deviation 180.37
|
|
Mean Weekly Dose of Study Drug Over Time
Week 349 - 360
|
389.6 mg
Standard Deviation 156.15
|
|
Mean Weekly Dose of Study Drug Over Time
Week 373 - 384
|
250.0 mg
Standard Deviation NA
NA=Standard Deviation cannot be calculated with N of 1.
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Participants who received at least 1 dose of study drug.
Dose adjustments include dose increases, dose interruptions, and dose reductions.
Outcome measures
| Measure |
Roxadustat
n=15 Participants
Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
|
|---|---|
|
Number of Participants With Dose Adjustments up to Week 52
Participants without Change
|
1 Participants
|
|
Number of Participants With Dose Adjustments up to Week 52
Participants with 1 Dose Increase
|
5 Participants
|
|
Number of Participants With Dose Adjustments up to Week 52
Participants with 2 Dose Increases
|
1 Participants
|
|
Number of Participants With Dose Adjustments up to Week 52
Participants with >2 Dose Increases
|
6 Participants
|
|
Number of Participants With Dose Adjustments up to Week 52
Participants with 1 Dose Interruption
|
1 Participants
|
|
Number of Participants With Dose Adjustments up to Week 52
Participants with 2 Dose Interruptions
|
1 Participants
|
|
Number of Participants With Dose Adjustments up to Week 52
Participants with >2 Dose Interruptions
|
0 Participants
|
|
Number of Participants With Dose Adjustments up to Week 52
Participants with 1 Dose Reduction
|
2 Participants
|
|
Number of Participants With Dose Adjustments up to Week 52
Participants with 2 Dose Reductions
|
8 Participants
|
|
Number of Participants With Dose Adjustments up to Week 52
Participants with >2 Dose Reductions
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 385Population: Participants who received at least 1 dose of study drug.
An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. Serious AE criteria included death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed here. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Roxadustat
n=15 Participants
Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Any TEAEs
|
14 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAEs
|
9 Participants
|
Adverse Events
Roxadustat
Serious events: 9 serious events
Other events: 14 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Roxadustat
n=15 participants at risk
Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
|
|---|---|
|
Blood and lymphatic system disorders
Hemorrhagic anaemia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute coronary syndrome
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular fibrillation
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
General disorders
Gait disturbance
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Shock hemorrhagic
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Roxadustat
n=15 participants at risk
Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Eye disorders
Cataract
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal hernia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
3/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Umbilical hernia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site rash
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abdominal infection
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abscess limb
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
20.0%
3/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Chikungunya virus infection
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Localised infection
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Mastoiditis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nail infection
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Onychomycosis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tinea pedis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
40.0%
6/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
3/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Vaginal infection
|
10.0%
1/10 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
20.0%
3/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
10.0%
1/10 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Investigations
Blood pressure increased
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Investigations
Serum ferritin decreased
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
20.0%
3/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
20.0%
3/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
3/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Diabetic neuropathy
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuralgia
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Product Issues
Thrombosis in device
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
10.0%
1/10 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
20.0%
2/10 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
5/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Blister
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Social circumstances
Loss of personal independence in daily activities
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
13.3%
2/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
6.7%
1/15 • Baseline up to Week 385
Participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The multisite consortium can publish any time after the data is collected and analyzed by FibroGen. The investigator can only publish after the multisite consortium publishes (or tries to publish and fails). FibroGen has 60 days to review a publication and can extend the embargo up to an additional 120 days (or 180 total).
- Publication restrictions are in place
Restriction type: OTHER