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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Failure; End Stage Renal Disease; ESRD; Kidney Failure; Hyperphosphatemia
• Intervention / Treatment: Drug: ferric citrate

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 Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Rio Piedras, Puerto Rico
    • RCMI-Clinical Research Center
• United States
  • California
    • Los Angeles, California, United States, 90073
      • Veterans Administration Greater Los Angeles Health Care System
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Westminster, Colorado, United States, 80031
      • Western Nephrology and Metabolic Bone Disease, PC
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Kidney Care Associates, LLC
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Circle Medical Management
  • Indiana
    • Michigan City, Indiana, United States, 46360
      • DaVita Dialysis Unit 494/Nephrology Specialists, PC
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Dept of Internal Medicine, Nephrology & Hypertension
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Washington Nephrology Associates
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Springfield, Massachusetts, United States, 01107
      • Western New England Renal & Transplant Associates, Pc
  • Michigan
    • Dearborn,, Michigan, United States, 48124
      • Nephrology Hypertension Clinic, PC
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Pontiac, Michigan, United States, 48341
      • Rochester Hills DaVita Dialysis
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Asheville Kidney Center
    • Charlotte, North Carolina, United States, 28207
      • Metrolina Nephrology Associates, PA
    • Durham, North Carolina, United States, 27705
      • Duke University Dept of Medicine/Nephrology
    • Winston-Salem, North Carolina, United States, 27101
      • Piedmont Dialysis Center
  • Ohio
    • Canton, Ohio, United States, 44718
      • Clinical Research Limited
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
  • Tennessee
    • Chattanooga, Tennessee, United States, 37408
      • Southeast Renal Research Institute Nephrology Associates
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37205
      • Nephrology Associates, PC
  • Texas
    • Dallas, Texas, United States, 75390
      • Ut Southwestern Medical Center At Dallas
    • Houston, Texas, United States, 77030
      • Kidney Associates, PLLC
    • Houston, Texas, United States, 77030
      • Med Center Dialysis
    • Houston, Texas, United States, 77384
      • Kidney Specialists of North Houston, PLLC
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont/ Fletcher Allen Health Care: Renal Services
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Nephrology Clinical Research Center
    • Fairfax, Virginia, United States, 22030
      • Clinical Research & Consulting Center, LLC
    • Fairfax, Virginia, United States, 22033
      • Nephrology Associates of Northern Virginia, Inc.
    • Hampton, Virginia, United States, 23666
      • Butler Farms Dialysis
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Phosphorus- Baseline		Baseline
Serum Phosphorus- Week 48		48 weeks
Ferritin- Baseline		Baseline
Ferritin- Week 48		48 weeks
Transferrin Saturation (TSAT) - Baseline		Baseline
TSAT- Week 48		48 weeks
Hemoglobin- Baseline		Baseline
Hemoglobin- Week 48		48 weeks
IV Iron Use	Percent of subjects with No IV iron intake from first dose of study drug to Week 48	48 weeks

Collaborators and Investigators

• Sponsor: Keryx Biopharmaceuticals

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: March 12, 2012
• First Submitted That Met QC Criteria: March 13, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Estimate): July 13, 2016
• Last Update Submitted That Met QC Criteria: June 2, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Long Term; Safety Extension; Participation Limited
• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Phosphorus Metabolism Disorders; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency; Hyperphosphatemia
• Other Study ID Numbers: KRX-0502-307