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

Kidney Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191255
• Other study ID #: KRX-0502-304
• 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

Related Conditions & MeSH terms

• Hyperphosphatemia
• Kidney Failure
• Kidney Failure, Chronic
• Renal Insufficiency

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

External Links

•   Sponsor Website