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A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis

Primary Purpose

Hyperphosphatemia, Kidney Failure

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ferric citrate, ca acetate, sevelamer carbonate, placebo
Sponsored by
Keryx Biopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperphosphatemia focused on measuring ESRD, end-stage renal disease, dialysis, hemodialysis, peritoneal dialysis, hemodialysis (HD), peritoneal dialysis (PD), chronic renal insufficiency, phosphate binder, kidney failure, renal failure

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
  2. Age ≥18 years
  3. On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening
  4. Serum phosphorus ≥6.0 mg/dL for study entry
  5. Taking less than 3-18 pills/day of current phosphate binder
  6. Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate
  7. Willing and able to give informed consent
  8. Life expectancy >1 year

Exclusion Criteria:

  1. Parathyroidectomy within six months prior to Screening
  2. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
  3. History of multiple drug allergies or intolerances
  4. History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC)
  5. Previous intolerance to oral ferric citrate
  6. Intolerance to oral iron-containing products
  7. Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
  8. Inability to tolerate oral drug intake
  9. Intolerance to calcium acetate and sevelamer carbonate
  10. Any other medical condition that renders the patient unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the patient
  11. Receipt of any investigational drug within 30 days of Screening Visit (Visit 0)
  12. Inability to cooperate with study personnel or history of noncompliance
  13. Unsuitable for this trial per Investigator's clinical judgment.

Sites / Locations

  • Southwest Clinical Research Institute, LLC
  • Tower Nephrology Medical Group
  • Veterans Administration Greater Los Angeles Healthcare System, West Los Angeles
  • Apex Research of Riverside
  • American Institute of Research
  • University of Colorado Denver
  • Western Nephrology
  • PAB Clinical Research
  • Mayo Clinic
  • ASA Clinical Research, LLC
  • Ocala Kidney Group
  • Pines Clinical Research, Inc.
  • Kidney Care Associates, LLC
  • Atlanta Nephrology Referral Center
  • Circle Medical Management
  • Nephrology Specialists, PC
  • LSU Health Sciences Center Section of Nephrology and Hypertension Department of Internal Medicine
  • Rockville Dialysis Center
  • Tufts Medical Center
  • Pioneer Valley Nephrology
  • Western New England Renal & Transplant Associates
  • Henry Ford Hospital
  • Michigan Kidney Consultants, PC
  • Nephrology Hypertension Clinic
  • Kansas City VA Medical Center
  • Brookdale Physician's Dialysis Associates
  • Mountain Kidney and Hypertension Associates, PA
  • Metrolina Nephrology Associates, PA
  • Duke University Medical Center Division of Nephrology
  • Trial Management Associates
  • Wake Forest University School of Medicine
  • Clinical Research Limited
  • Division of Nephrology and Hypertension Department of Internal Medicine University of Cincinnati College of Medicine
  • Cleveland Clinic Foundation Q7-150 Nephrology
  • The Ohio State University Division of Nephrology
  • DaVita
  • University of Pennsylvania Health System
  • Southeast Renal Research Institute Nephrology Associates
  • Nephrology Associates, PC
  • Vanderbilt University Medical Center Clinical Trials Center
  • UT Southwestern Medical Center at Dallas
  • Kidney Associates
  • Nephrology, PA
  • Kidney Specialists of North Houston, PLLC
  • University of Utah Health Sciences Center
  • University of Vermont/ Fletcher Allen Health Care; Renal Services
  • Nephrology Clinical Research Center
  • Clinical Research & Consulting Center, LLC
  • Nephrology Associates of Northern Virginia, Inc.
  • Peninsula Kidney Associates
  • McGuire VA Medical Center
  • Medical College of Wisconsin Froedert Memorial Lutheran Hospital Division of Nephrology
  • Department of Nephrology and Hypertension Brazilai Medical Center
  • Tel Aviv Sourasky Medical Center Nephrology Department
  • RCMI-Clinical Research Center Medical Sciences Campus University of Puerto Rico
  • Puerto Rico Renal Health & Research Center, Inc/ Atlantic Healthcare Group, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Active Control

Placebo

KRX-0502 (Ferric Citrate)

Arm Description

PhosLo (calcium acetate) Renvela (sevelamer carbonate)

Placebo

ferric citrate

Outcomes

Primary Outcome Measures

Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56)
Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks.

Secondary Outcome Measures

Change in Mean Serum Ferritin From Baseline to Week 52
Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52)
IV Iron Analysis
Full Analysis Population, cumulative IV Iron administration from Baseline to the end of the Safety Assessment Period (Week 52)
ESA Analysis
Full analysis population, cumulative Erythropoiesis-stimulating agent (ESA) administration from baseline to the end of the Safety Assessment Period (Week 52)

Full Information

First Posted
August 26, 2010
Last Updated
December 8, 2014
Sponsor
Keryx Biopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01191255
Brief Title
A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
Official Title
A Three-Period, 58-Week Safety and Efficacy 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
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (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
This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.
Detailed Description
This trial is a three-period, multicenter, safety and efficacy clinical trial. The first period is a two-week Washout Period, the second period is a 52-week randomized, open-label, active control Safety Assessment Period, and the third period is a four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period in only the patients who were randomized to treatment with ferric citrate during the Safety Assessment Period. The primary objectives of this trial are to determine the long-term safety over 52 weeks of up to twelve (12) caplets/day of KRX-0502 (ferric citrate) in patients with ESRD undergoing either hemodialysis or peritoneal dialysis and to determine the efficacy of KRX-0502 (ferric citrate) in the four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia, Kidney Failure
Keywords
ESRD, end-stage renal disease, dialysis, hemodialysis, peritoneal dialysis, hemodialysis (HD), peritoneal dialysis (PD), chronic renal insufficiency, phosphate binder, kidney failure, renal failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
441 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
PhosLo (calcium acetate) Renvela (sevelamer carbonate)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
KRX-0502 (Ferric Citrate)
Arm Type
Experimental
Arm Description
ferric citrate
Intervention Type
Drug
Intervention Name(s)
ferric citrate, ca acetate, sevelamer carbonate, placebo
Other Intervention Name(s)
PhosLo, Renvela, KRX-0502, Zerenex
Intervention Description
All intervention doses will be based on serum phosphorus levels and/or drug label requirements
Primary Outcome Measure Information:
Title
Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56)
Description
Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in Mean Serum Ferritin From Baseline to Week 52
Time Frame
52 weeks
Title
Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52)
Time Frame
52 weeks
Title
IV Iron Analysis
Description
Full Analysis Population, cumulative IV Iron administration from Baseline to the end of the Safety Assessment Period (Week 52)
Time Frame
52 weeks
Title
ESA Analysis
Description
Full analysis population, cumulative Erythropoiesis-stimulating agent (ESA) administration from baseline to the end of the Safety Assessment Period (Week 52)
Time Frame
52 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 Age ≥18 years On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening Serum phosphorus ≥6.0 mg/dL for study entry Taking less than 3-18 pills/day of current phosphate binder Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate Willing and able to give informed consent Life expectancy >1 year Exclusion Criteria: Parathyroidectomy within six months prior to Screening Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease History of multiple drug allergies or intolerances History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC) Previous intolerance to oral ferric citrate Intolerance to oral iron-containing products Psychiatric disorder that interferes with the patient's ability to comply with the study protocol Inability to tolerate oral drug intake Intolerance to calcium acetate and sevelamer carbonate Any other medical condition that renders the patient unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the patient Receipt of any investigational drug within 30 days of Screening Visit (Visit 0) Inability to cooperate with study personnel or history of noncompliance Unsuitable for this trial per Investigator's 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
First Name & Middle Initial & Last Name & Degree
Samuel Blumenthal, MD
Organizational Affiliation
Collaborative Study Group
Official's Role
Study Chair
Facility Information:
Facility Name
Southwest Clinical Research Institute, LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Tower Nephrology Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Veterans Administration Greater Los Angeles Healthcare System, West Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Apex Research of Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
American Institute of Research
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Western Nephrology
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80031
Country
United States
Facility Name
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
ASA Clinical Research, LLC
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Ocala Kidney Group
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Pines Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Kidney Care Associates, LLC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Atlanta Nephrology Referral Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Circle Medical Management
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Nephrology Specialists, PC
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
LSU Health Sciences Center Section of Nephrology and Hypertension Department of Internal Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Rockville Dialysis Center
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Pioneer Valley Nephrology
City
Holyoke
State/Province
Massachusetts
ZIP/Postal Code
01040
Country
United States
Facility Name
Western New England Renal & Transplant Associates
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Michigan Kidney Consultants, PC
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Nephrology Hypertension Clinic
City
Southgate
State/Province
Michigan
ZIP/Postal Code
48195
Country
United States
Facility Name
Kansas City VA Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Brookdale Physician's Dialysis Associates
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Name
Mountain Kidney and Hypertension Associates, PA
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 Medical Center Division of Nephrology
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Trial Management Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Clinical Research Limited
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Division of Nephrology and Hypertension Department of Internal Medicine University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic Foundation Q7-150 Nephrology
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Division of Nephrology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
DaVita
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
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
37404
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 Clinical Trials Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-1371
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
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Nephrology, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Kidney Specialists of North Houston, PLLC
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
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
Peninsula Kidney Associates
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Medical College of Wisconsin Froedert Memorial Lutheran Hospital Division of Nephrology
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Department of Nephrology and Hypertension Brazilai Medical Center
City
Ashkelon
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center Nephrology Department
City
Tel Aviv
Country
Israel
Facility Name
RCMI-Clinical Research Center Medical Sciences Campus University of Puerto Rico
City
Rio Piedras
ZIP/Postal Code
00936-5067
Country
Puerto Rico
Facility Name
Puerto Rico Renal Health & Research Center, Inc/ Atlantic Healthcare Group, Inc
City
Trujillo Alto
ZIP/Postal Code
00976
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
26239948
Citation
Rodby RA, Umanath K, Niecestro R, Bond TC, Sika M, Lewis J, Dwyer JP; Collaborative Study Group. Ferric Citrate, an Iron-Based Phosphate Binder, Reduces Health Care Costs in Patients on Dialysis Based on Randomized Clinical Trial Data. Drugs R D. 2015 Sep;15(3):271-9. doi: 10.1007/s40268-015-0103-y.
Results Reference
derived
Links:
URL
http://www.keryx.com
Description
Sponsor Website

Learn more about this trial

A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis

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