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

Primary Purpose

End Stage Renal Disease, Kidney Failure, Renal Failure

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ferric citrate
Sponsored by
Keryx Biopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Participation Limited, Long Term, Safety Extension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Veterans Administration Greater Los Angeles Health Care System
  • University of Colorado
  • Western Nephrology and Metabolic Bone Disease, PC
  • Kidney Care Associates, LLC
  • Circle Medical Management
  • DaVita Dialysis Unit 494/Nephrology Specialists, PC
  • Dept of Internal Medicine, Nephrology & Hypertension
  • Washington Nephrology Associates
  • Tufts Medical Center
  • Western New England Renal & Transplant Associates, PC
  • Nephrology Hypertension Clinic, PC
  • Henry Ford Hospital
  • Rochester Hills DaVita Dialysis
  • Asheville Kidney Center
  • Metrolina Nephrology Associates, PA
  • Duke University Dept of Medicine/Nephrology
  • Piedmont Dialysis Center
  • Clinical Research Limited
  • University of Cincinnati
  • University of Pennsylvania Health System
  • Southeast Renal Research Institute Nephrology Associates
  • Nephrology Associates, PC
  • Vanderbilt University Medical Center
  • UT Southwestern Medical Center at Dallas
  • Kidney Associates, PLLC
  • Med Center Dialysis
  • Kidney Specialists of North Houston, PLLC
  • University of Vermont/ Fletcher Allen Health Care: Renal Services
  • Nephrology Clinical Research Center
  • Clinical Research & Consulting Center, LLC
  • Nephrology Associates of Northern Virginia, Inc.
  • Butler Farms Dialysis
  • Medical College of Wisconsin
  • RCMI-Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ferric Citrate

Arm Description

Open label extension of those completing study KRX-0304

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
March 12, 2012
Last Updated
June 2, 2016
Sponsor
Keryx Biopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01554982
Brief Title
A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis
Official Title
A Long-Term Safety Extension Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keryx Biopharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Kidney Failure, Renal Failure, Hyperphosphatemia, ESRD
Keywords
Participation Limited, Long Term, Safety Extension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferric Citrate
Arm Type
Other
Arm Description
Open label extension of those completing study KRX-0304
Intervention Type
Drug
Intervention Name(s)
ferric citrate
Other Intervention Name(s)
Auryxia, KRX-0502
Intervention Description
Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Primary Outcome Measure Information:
Title
Safety Parameters
Description
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).
Time Frame
48 Weeks
Other Pre-specified Outcome Measures:
Title
Serum Phosphorus- Baseline
Time Frame
Baseline
Title
Serum Phosphorus- Week 48
Time Frame
48 weeks
Title
Ferritin- Baseline
Time Frame
Baseline
Title
Ferritin- Week 48
Time Frame
48 weeks
Title
Transferrin Saturation (TSAT) - Baseline
Time Frame
Baseline
Title
TSAT- Week 48
Time Frame
48 weeks
Title
Hemoglobin- Baseline
Time Frame
Baseline
Title
Hemoglobin- Week 48
Time Frame
48 weeks
Title
IV Iron Use
Description
Percent of subjects with No IV iron intake from first dose of study drug to Week 48
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia B Lewis, MD
Organizational Affiliation
Collaborative Study Group
Official's Role
Study Chair
Facility Information:
Facility Name
Veterans Administration Greater Los Angeles Health Care System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Western Nephrology and Metabolic Bone Disease, PC
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80031
Country
United States
Facility Name
Kidney Care Associates, LLC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Circle Medical Management
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
DaVita Dialysis Unit 494/Nephrology Specialists, PC
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
Dept of Internal Medicine, Nephrology & Hypertension
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Washington Nephrology Associates
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Western New England Renal & Transplant Associates, PC
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Nephrology Hypertension Clinic, PC
City
Dearborn,
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Rochester Hills DaVita Dialysis
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Asheville Kidney Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Metrolina Nephrology Associates, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Duke University Dept of Medicine/Nephrology
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Piedmont Dialysis Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Clinical Research Limited
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Southeast Renal Research Institute Nephrology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37408
Country
United States
Facility Name
Nephrology Associates, PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
UT Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Kidney Associates, PLLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Med Center Dialysis
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Kidney Specialists of North Houston, PLLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
University of Vermont/ Fletcher Allen Health Care: Renal Services
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Nephrology Clinical Research Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Clinical Research & Consulting Center, LLC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
Nephrology Associates of Northern Virginia, Inc.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
Facility Name
Butler Farms Dialysis
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
RCMI-Clinical Research Center
City
Rio Piedras
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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