A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis

Study Overview
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Brief Summary
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A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may participate in this trial.

Detailed Description
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This study was an open-label, 48-week safety extension of Study KRX-0502-304 (Study 304), to evaluate the safety of long-term use of KRX-0502 in subjects with ESRD for up to 2 years of cumulative exposure. Subjects who completed the Safety Assessment Period (SAP) and, if eligible, the Efficacy Assessment Period (EAP) of Study 304, independent of their assigned treatment arm in the SAP or EAP of Study 304, were eligible for participation in this long-term safety extension study. No new subjects were permitted to enter this study.

Official Title
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A Long-Term Safety Extension Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis

Conditions
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End Stage Renal Disease, Kidney Failure, Renal Failure, Hyperphosphatemia, ESRD

Intervention / Treatment
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* Drug: ferric citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or non-pregnant, non-breast-feeding females who participated in the Safety Assessment Period (SAP), and if eligible, the Efficacy Assessment Period (EAP) of Study KRX-0502-304 Willing and able to give informed consent Exclusion Criteria: Subjects on KRX-0502 (ferric citrate) in KRX-0502-304 who were treatment failures in first period Any subject in Study KRX-0502-304 SAP who early terminated from the trial Any subject who participated in Study KRX-0502-304 but declined EAP Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease History of malignancy in the last five years Previous intolerance to KRX-0502 (ferric citrate) Intolerance to oral iron-containing products Absolute requirement for oral iron therapy Absolute requirement for Vitamin C (multivitamins [Nephrocaps, Renaphro, etc.] allowed) Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals Inability to tolerate oral drug intake Any other medical condition that rendered the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject Inability to cooperate with study personnel or history of noncompliance Unsuitable for this trial per Principal Investigator's (PI) clinical judgment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ferric Citrate<br>Open label extension of those completing study KRX-0304 | Drug: ferric citrate<br>* Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.<br>* Other names: KRX-0502;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Parameters | Safety was assessed by recording and monitoring adverse events (AEs), serious adverse events (SAEs), and sequential laboratory data. Rates of AEs were summarized by system organ class, preferred term, severity, and suspected relationship to KRX-0502 (ferric citrate). | 48 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Participation Limited, Long Term, Safety Extension