Trial Outcomes & Findings for Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease (NCT NCT05085275)

NCT ID: NCT05085275

Last Updated: 2025-08-29

Results Overview

Number of participants achieving a composite endpoint of initiation of maintenance dialysis or all-cause mortality

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

289 participants

Primary outcome timeframe

9 months

Results posted on

2025-08-29

Participant Flow

This was a randomized, double-blind, placebo-controlled clinical trial to assess the effect of ferric citrate on the time to a composite endpoint of initiation of maintenance dialysis or all-cause mortality compared with placebo in adults with advanced chronic kidney disease.

A total of 289 patients were randomized 1:1 to receive ferric citrate (n=144) or placebo (n=145).

Participant milestones

Participant milestones
Measure	Ferric Citrate Supplied as tablets for oral administration containing 1 gram ferric citrate (210 milligrams of ferric iron). Administered orally with meals or snacks.	Placebo Tablets, matching in color and size to ferric citrate.
Overall Study STARTED	144	145
Overall Study Received Day 1 Dose	138	136
Overall Study COMPLETED	88	77
Overall Study NOT COMPLETED	56	68

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ferric Citrate n=138 Participants Supplied as tablets for oral administration containing 1 gram ferric citrate (210 milligrams of ferric iron). Administered orally with meals or snacks.	Placebo n=136 Participants Tablets, matching in color and size to ferric citrate.	Total n=274 Participants Total of all reporting groups
Age, Continuous	66.3 years STANDARD_DEVIATION 13.1 • n=39 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	68.2 years STANDARD_DEVIATION 12.9 • n=41 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	67 years STANDARD_DEVIATION 13 • n=35 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).
Sex: Female, Male Female	79 Participants n=39 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	71 Participants n=41 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	150 Participants n=35 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).
Sex: Female, Male Male	59 Participants n=39 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	65 Participants n=41 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	124 Participants n=35 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	0 Participants n=41 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	0 Participants n=35 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).
Race (NIH/OMB) Asian	0 Participants n=39 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	0 Participants n=41 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	0 Participants n=35 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	0 Participants n=41 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	0 Participants n=35 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).
Race (NIH/OMB) Black or African American	24 Participants n=39 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	21 Participants n=41 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	45 Participants n=35 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).
Race (NIH/OMB) White	94 Participants n=39 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	97 Participants n=41 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	191 Participants n=35 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).
Race (NIH/OMB) More than one race	0 Participants n=39 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	0 Participants n=41 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	0 Participants n=35 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=39 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	18 Participants n=41 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	38 Participants n=35 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).
Comorbid conditions at baseline Atherosclerotic cardiovascular disease	41 Participants n=39 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	55 Participants n=41 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	96 Participants n=35 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).
Comorbid conditions at baseline Congestive heart failure	20 Participants n=39 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	30 Participants n=41 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	50 Participants n=35 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).
Comorbid conditions at baseline Diabetes	92 Participants n=39 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	86 Participants n=41 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).	178 Participants n=35 Participants • Total number of patients should be 274: (Ferric citrate (N=138) and Placebo (N=136).

PRIMARY outcome

Timeframe: 9 months

Population: Full analysis set which consists of randomized patients who received one or more doses of study drug.

Number of participants achieving a composite endpoint of initiation of maintenance dialysis or all-cause mortality

Outcome measures

Outcome measures
Measure	Ferric Citrate n=138 Participants Supplied as tablets for oral administration containing 1 gram ferric citrate (210 milligrams of ferric iron). Administered orally with meals or snacks.	Placebo n=136 Participants Tablets, matching in color and size to ferric citrate.
Number of Participants Achieving a Composite Endpoint of Initiation of Maintenance Dialysis or All-cause Mortality	35 Participants	46 Participants

SECONDARY outcome

Timeframe: 9 months

Population: Full analysis set population which consists of all randomized patients who received one or more doses of study drug.

Number of hospitalization events reported as a serious adverse event (SAE) (excluding disease-related hospitalization \[e.g., dialysis access placement, dialysis initiation, kidney transplant\] and elective procedures)

Outcome measures

Outcome measures
Measure	Ferric Citrate n=138 Participants Supplied as tablets for oral administration containing 1 gram ferric citrate (210 milligrams of ferric iron). Administered orally with meals or snacks.	Placebo n=136 Participants Tablets, matching in color and size to ferric citrate.
Hospitalization Events Reported as a Serious Adverse Event (SAE) (Excluding Disease-related Hospitalization [e.g., Dialysis Access Placement, Dialysis Initiation, Kidney Transplant] and Elective Procedures)	1.1 Number of hospitalizations per patient Standard Deviation 2.4	2.5 Number of hospitalizations per patient Standard Deviation 9.4

SECONDARY outcome

Timeframe: 9 months

Population: Full analysis set population which consists of all randomized patients who received one or more doses of study drug.

Component of Primary - Number of participants initiating maintenance dialysis

Outcome measures

Outcome measures
Measure	Ferric Citrate n=138 Participants Supplied as tablets for oral administration containing 1 gram ferric citrate (210 milligrams of ferric iron). Administered orally with meals or snacks.	Placebo n=136 Participants Tablets, matching in color and size to ferric citrate.
Component of Primary - Initiation of Maintenance Dialysis	24 Participants	29 Participants

SECONDARY outcome

Timeframe: 9 months

Population: Full analysis set population which consists of all randomized patients who received one or more doses of study drug.

Component of Primary - Number of patients reaching endpoint of all-cause mortality.

Outcome measures

Outcome measures
Measure	Ferric Citrate n=138 Participants Supplied as tablets for oral administration containing 1 gram ferric citrate (210 milligrams of ferric iron). Administered orally with meals or snacks.	Placebo n=136 Participants Tablets, matching in color and size to ferric citrate.
Component of Primary - All-Cause Mortality	1 Participants	4 Participants

Adverse Events

Ferric Citrate

Serious events: 33 serious events

Other events: 0 other events

Deaths: 2 deaths

Placebo

Serious events: 43 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Stephanie Brillhart, Senior Director Regulatory Compliance

USRC Kidney Research

Phone: 303-881-9451

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No publication or disclosure of study results will be permitted, except under the terms and conditions of a separate, written agreement between Investigator-Sponsor and the Investigator and/or the Investigator's institution. The Investigator-Sponsor will have the opportunity to review and approve all proposed abstracts, manuscripts, or presentations regarding this study prior to submission for publication/presentation.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Ferric Citrate n=138 participants at risk Supplied as tablets for oral administration containing 1 gram ferric citrate (210 milligrams of ferric iron). Administered orally with meals or snacks.	Placebo n=136 participants at risk Tablets, matching in color and size to ferric citrate.
Blood and lymphatic system disorders Anaemia	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	2.9% 4/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Cardiac disorders Cardiac failure congestive	4.3% 6/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	4.4% 6/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Cardiac disorders Cardiac arrest	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	2.9% 4/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Cardiac disorders Atrial fibrillation	0.00% 0/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Cardiac disorders Cardiac failure	0.00% 0/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Cardiac disorders Coronary artery disease	0.00% 0/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Eye disorders Retinal artery occlusion	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.00% 0/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Gastrointestinal disorders Ileus	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.00% 0/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Gastrointestinal disorders Intestinal ischaemia	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.00% 0/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Gastrointestinal disorders Enterocolitis	0.00% 0/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Gastrointestinal disorders Gastric ulcer	0.00% 0/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
General disorders Asthenia	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.00% 0/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
General disorders Death	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.00% 0/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
General disorders Cardiac death	0.00% 0/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Hepatobiliary disorders Cholecystitis	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.00% 0/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Hepatobiliary disorders Hepatic cirrhosis	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.00% 0/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Infections and infestations Sepsis	2.2% 3/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Infections and infestations Pyelonephritis	1.4% 2/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.00% 0/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Infections and infestations Cellulitis	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.00% 0/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Infections and infestations Osteomyelitis	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Infections and infestations Pneumonia	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	2.2% 3/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Infections and infestations Skin infection	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.00% 0/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Infections and infestations COVID-19	0.00% 0/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Infections and infestations Emphysematous cystitis	0.00% 0/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Infections and infestations Gastroenteritis	0.00% 0/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	1.5% 2/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Infections and infestations Urinary tract infection	0.00% 0/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Injury, poisoning and procedural complications Fall	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Injury, poisoning and procedural complications Femoral neck fracture	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.00% 0/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Injury, poisoning and procedural complications Hip fracture	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	1.5% 2/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Injury, poisoning and procedural complications Tibia fracture	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.00% 0/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Metabolism and nutrition disorders Hypophosphataemia	1.4% 2/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.00% 0/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Metabolism and nutrition disorders Fluid overload	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	1.5% 2/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Metabolism and nutrition disorders Hypervolaemia	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Metabolism and nutrition disorders Hypocalcaemia	0.72% 1/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.00% 0/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/138 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.	0.74% 1/136 • Serious Adverse Events and Adverse Events of Special Interest were collected from initiation of study drug treatment through the 10 months. Only Serious Adverse Events and Adverse Events of Special Interest (Iron Overload and Clinically Significant Hypophosphatemia) were collected.