Phase 3
Completed N=441
A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
Hyperphosphatemia · Chronic Kidney Disease
Source: ClinicalTrials.gov NCT01191255 ↗
Enrolled (actual)
441
Serious AEs
34.2%
Results posted
Dec 2014
Primary outcomePrimary: Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) — 5.44; 5.12; 7.23; 4.89 mg/dL — p=<0.0001
Summary
This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) |
5.44; 5.12; 7.23; 4.89 | <0.0001 sig |
| SECONDARY Change in Mean Serum Ferritin From Baseline to Week 52 |
609.50; 592.80; 631.87; 894.88 | <0.0001 sig |
| SECONDARY Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52) |
30.8; 31.3; 29.7; 39.2 | <0.0001 sig |
| SECONDARY IV Iron Analysis |
3.83; 1.87 | <0.0001 sig |
| SECONDARY ESA Analysis |
993.46; 755.80 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Males or non-pregnant, non-breast-feeding females
- Age ≥18 years
- On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening
- Serum phosphorus ≥6.0 mg/dL for study entry
- Taking less than 3-18 pills/day of current phosphate binder
- Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate
- Willing and able to give informed consent
- Life expectancy >1 year
Exclusion Criteria
- Parathyroidectomy within six months prior to Screening
- Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
- History of multiple drug allergies or intolerances
- History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC)
- Previous intolerance to oral ferric citrate
- Intolerance to oral iron-containing products
- Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
- Inability to tolerate oral drug intake
- Intolerance to calcium acetate and sevelamer carbonate
- Any other medical condition that renders the patient unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the patient
- Receipt of any investigational drug within 30 days of Screening Visit (Visit 0)
- Inability to cooperate with study personnel or history of noncompliance
- Unsuitable for this trial per Investigator's clinical judgment.
Data sourced from ClinicalTrials.gov (NCT01191255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.