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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01191255
Other study ID # KRX-0502-304
Secondary ID
Status Completed
Phase Phase 3
First received August 26, 2010
Last updated December 8, 2014
Start date October 2010
Est. completion date February 2013

Study information

Verified date December 2014
Source Keryx Biopharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationIsrael: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 441
Est. completion date February 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Drug:
ferric citrate, ca acetate, sevelamer carbonate, placebo
All intervention doses will be based on serum phosphorus levels and/or drug label requirements

Locations

Country Name City State
Israel Department of Nephrology and Hypertension Brazilai Medical Center Ashkelon
Israel Tel Aviv Sourasky Medical Center Nephrology Department Tel Aviv
Puerto Rico RCMI-Clinical Research Center Medical Sciences Campus University of Puerto Rico Rio Piedras
Puerto Rico Puerto Rico Renal Health & Research Center, Inc/ Atlantic Healthcare Group, Inc Trujillo Alto
United States Mountain Kidney and Hypertension Associates, PA Asheville North Carolina
United States Kidney Care Associates, LLC Augusta Georgia
United States University of Colorado Denver Aurora Colorado
United States Tufts Medical Center Boston Massachusetts
United States PAB Clinical Research Brandon Florida
United States Brookdale Physician's Dialysis Associates Brooklyn New York
United States University of Vermont/ Fletcher Allen Health Care; Renal Services Burlington Vermont
United States Clinical Research Limited Canton Ohio
United States Metrolina Nephrology Associates, PA Charlotte North Carolina
United States Nephrology Clinical Research Center Charlottesville Virginia
United States Southeast Renal Research Institute Nephrology Associates Chattanooga Tennessee
United States Circle Medical Management Chicago Illinois
United States Division of Nephrology and Hypertension Department of Internal Medicine University of Cincinnati College of Medicine Cincinnati Ohio
United States Cleveland Clinic Foundation Q7-150 Nephrology Cleveland Ohio
United States The Ohio State University Division of Nephrology Columbus Ohio
United States UT Southwestern Medical Center at Dallas Dallas Texas
United States Atlanta Nephrology Referral Center Decatur Georgia
United States Henry Ford Hospital Detroit Michigan
United States Duke University Medical Center Division of Nephrology Durham North Carolina
United States Clinical Research & Consulting Center, LLC Fairfax Virginia
United States Nephrology Associates of Northern Virginia, Inc. Fairfax Virginia
United States Peninsula Kidney Associates Hampton Virginia
United States Pioneer Valley Nephrology Holyoke Massachusetts
United States Kidney Associates Houston Texas
United States Nephrology, PA Houston Texas
United States Mayo Clinic Jacksonville Florida
United States ASA Clinical Research, LLC Jupiter Florida
United States Kansas City VA Medical Center Kansas City Missouri
United States Tower Nephrology Medical Group Los Angeles California
United States Veterans Administration Greater Los Angeles Healthcare System, West Los Angeles Los Angeles California
United States Nephrology Specialists, PC Michigan City Indiana
United States Medical College of Wisconsin Froedert Memorial Lutheran Hospital Division of Nephrology Milwaukee Wisconsin
United States Nephrology Associates, PC Nashville Tennessee
United States Vanderbilt University Medical Center Clinical Trials Center Nashville Tennessee
United States LSU Health Sciences Center Section of Nephrology and Hypertension Department of Internal Medicine New Orleans Louisiana
United States Ocala Kidney Group Ocala Florida
United States DaVita Oklahoma City Oklahoma
United States Pines Clinical Research, Inc. Pembroke Pines Florida
United States University of Pennsylvania Health System Philadelphia Pennsylvania
United States Michigan Kidney Consultants, PC Pontiac Michigan
United States McGuire VA Medical Center Richmond Virginia
United States Apex Research of Riverside Riverside California
United States Rockville Dialysis Center Rockville Maryland
United States University of Utah Health Sciences Center Salt Lake City Utah
United States Nephrology Hypertension Clinic Southgate Michigan
United States Western New England Renal & Transplant Associates Springfield Massachusetts
United States Southwest Clinical Research Institute, LLC Tempe Arizona
United States Kidney Specialists of North Houston, PLLC The Woodlands Texas
United States Western Nephrology Westminster Colorado
United States American Institute of Research Whittier California
United States Trial Management Associates Wilmington North Carolina
United States Wake Forest University School of Medicine Winston Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Keryx Biopharmaceuticals

Countries where clinical trial is conducted

United States,  Israel,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks Yes
Secondary Change in Mean Serum Ferritin From Baseline to Week 52 52 weeks Yes
Secondary Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52) 52 weeks Yes
Secondary IV Iron Analysis Full Analysis Population, cumulative IV Iron administration from Baseline to the end of the Safety Assessment Period (Week 52) 52 weeks No
Secondary ESA Analysis Full analysis population, cumulative Erythropoiesis-stimulating agent (ESA) administration from baseline to the end of the Safety Assessment Period (Week 52) 52 weeks No
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