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
• Interventions: Drug: ferric citrate

• Registration Number: NCT01554982
• Lead Sponsor: Keryx Biopharmaceuticals

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.

Study Timeline

• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-15
• Study Start: 2012-08
• Primary Completion: 2014-06
• Study Completion: 2014-08
• Results First Submitted: 2015-09-24
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-02
• Last Update Submitted: 2016-06-02
• Results First Posted: 2016-07-13
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

1. 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
2. Willing and able to give informed consent

Exclusion Criteria

1. Subjects on KRX-0502 (ferric citrate) in KRX-0502-304 who were treatment failures in first period
2. Any subject in Study KRX-0502-304 SAP who early terminated from the trial
3. Any subject who participated in Study KRX-0502-304 but declined EAP
4. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
5. History of malignancy in the last five years
6. Previous intolerance to KRX-0502 (ferric citrate)
7. Intolerance to oral iron-containing products
8. Absolute requirement for oral iron therapy
9. Absolute requirement for Vitamin C (multivitamins [Nephrocaps, Renaphro, etc.] allowed)
10. Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
11. Inability to tolerate oral drug intake
12. 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
13. Inability to cooperate with study personnel or history of noncompliance
14. Unsuitable for this trial per Principal Investigator's (PI) clinical judgment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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).

Trial Locations

Locations (34)

Kidney Care Associates, LLC; 🇺🇸 Augusta, Georgia, United States

Asheville Kidney Center; 🇺🇸 Asheville, North Carolina, United States

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States

Southeast Renal Research Institute Nephrology Associates; 🇺🇸 Chattanooga, Tennessee, United States

University of Vermont/ Fletcher Allen Health Care: Renal Services; 🇺🇸 Burlington, Vermont, United States

Nephrology Associates of Northern Virginia, Inc.; 🇺🇸 Fairfax, Virginia, United States

Circle Medical Management; 🇺🇸 Chicago, Illinois, United States

Med Center Dialysis; 🇺🇸 Houston, Texas, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Kidney Specialists of North Houston, PLLC; 🇺🇸 Houston, Texas, United States

Kidney Associates, PLLC; 🇺🇸 Houston, Texas, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Duke University Dept of Medicine/Nephrology; 🇺🇸 Durham, North Carolina, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Western Nephrology and Metabolic Bone Disease, PC; 🇺🇸 Westminster, Colorado, United States

RCMI-Clinical Research Center; 🇵🇷 Rio Piedras, Puerto Rico

Clinical Research Limited; 🇺🇸 Canton, Ohio, United States

Veterans Administration Greater Los Angeles Health Care System; 🇺🇸 Los Angeles, California, United States

DaVita Dialysis Unit 494/Nephrology Specialists, PC; 🇺🇸 Michigan City, Indiana, United States

Nephrology Hypertension Clinic, PC; 🇺🇸 Dearborn,, Michigan, United States

Rochester Hills DaVita Dialysis; 🇺🇸 Pontiac, Michigan, United States

Metrolina Nephrology Associates, PA; 🇺🇸 Charlotte, North Carolina, United States

UT Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States

Butler Farms Dialysis; 🇺🇸 Hampton, Virginia, United States

Nephrology Clinical Research Center; 🇺🇸 Charlottesville, Virginia, United States

Clinical Research & Consulting Center, LLC; 🇺🇸 Fairfax, Virginia, United States

Dept of Internal Medicine, Nephrology & Hypertension; 🇺🇸 New Orleans, Louisiana, United States

Western New England Renal & Transplant Associates, PC; 🇺🇸 Springfield, Massachusetts, United States

Nephrology Associates, PC; 🇺🇸 Nashville, Tennessee, United States

Washington Nephrology Associates; 🇺🇸 Bethesda, Maryland, United States

Piedmont Dialysis Center; 🇺🇸 Winston-Salem, North Carolina, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States