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

Phase 3

Completed

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

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Ferric Citrate	ferric citrate	Open label extension of those completing study KRX-0304

Primary Outcome Measures

Name	Time	Method
Safety Parameters	48 Weeks	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).

Secondary Outcome Measures

Name	Time	Method

Locations (34): Veterans Administration Greater Los Angeles Health Care System
🇺🇸
Los Angeles, California, United States
University of Colorado
🇺🇸
Aurora, Colorado, United States
Western Nephrology and Metabolic Bone Disease, PC
🇺🇸
Westminster, Colorado, United States
Kidney Care Associates, LLC
🇺🇸
Augusta, Georgia, United States
Circle Medical Management
🇺🇸
Chicago, Illinois, United States
DaVita Dialysis Unit 494/Nephrology Specialists, PC
🇺🇸
Michigan City, Indiana, United States
Dept of Internal Medicine, Nephrology & Hypertension
🇺🇸
New Orleans, Louisiana, United States
Washington Nephrology Associates
🇺🇸
Bethesda, Maryland, United States
Tufts Medical Center
🇺🇸
Boston, Massachusetts, United States
Western New England Renal & Transplant Associates, PC
🇺🇸
Springfield, Massachusetts, United States
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Veterans Administration Greater Los Angeles Health Care System
🇺🇸Los Angeles, California, United States