A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
1 other identifier
interventional
154
2 countries
16
Brief Summary
This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2010
Shorter than P25 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2010
CompletedFirst Posted
Study publicly available on registry
February 24, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
December 4, 2014
CompletedDecember 4, 2014
December 1, 2014
6 months
February 17, 2010
October 4, 2014
December 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Serum Phosphorus From Baseline to End of Treatment
Mean change from baseline was calculated separately for each treatment arm (LOCF)
Baseline and day 28
Secondary Outcomes (2)
Pairwise Comparison of the Mean Change in Serum Phosphorus From Baseline to the End of Treatment
Baseline and day 28
Proportion of Patient With a Serum Phosphorus ≤5.5 mg/dL at the End of Treatment
Baseline and day 28
Study Arms (3)
1 g/day
EXPERIMENTAL1 g/day KRX-0502 (ferric citrate)
6 g/day
EXPERIMENTAL6 g/day KRX-0502 (ferric citrate)
8 g/day
EXPERIMENTAL8 g/day KRX-0502 (ferric citrate)
Interventions
1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days
Eligibility Criteria
You may qualify if:
- Males or non-pregnant, non-lactating females
- Age \> 18 years
- On thrice weekly hemodialysis or peritoneal dialysis for at least the previous three months prior to Screening Visit (Visit 0)
- Serum phosphorus levels ≥ 3.5 mg/dL and \< 8.0 mg/dL at Screening Visit (Visit 0)
- Serum phosphorus levels \> 6.0 mg/dL during the washout period (Visits 2 or 3)
- Taking 3 to 15 tablets/capsules per day of 667mg calcium acetate or 800 mg sevelamer (hydrochloride or carbonate), or any combination of these agents as reported by the patient at Screening Visit (Visit 0)
- Serum ferritin \<1000micrograms/L and Transferrin Saturation (TSAT) \<50% at the Screening Visit (Visit 0)
- Willingness to be discontinued from current phosphate binder(s) and initiated on KRX-0502 (ferric citrate)
- Willing and able to give informed consent
- Willing and able to stay on a constant dose of Vitamin D (or its analogs) and Sensipar (cinacalcet) for the treatment period, if applicable.
You may not qualify if:
- Parathyroidectomy within six months prior to Screening Visit (Visit 0)
- Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
- Serum phosphorus levels \>10.0 mg/dL documented in all of the three monthly laboratories (done routinely in the dialysis unit) in the three months prior to the Screening Visit (Visit 0)
- 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
- 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
- Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
- Inability to tolerate oral drug intake
- Planned surgery or hospitalization during the trial (scheduled outpatient access surgery allowed)
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Keryx Biopharmaceuticalslead
- Collaborative Study Group (CSG)collaborator
Study Sites (16)
Western Nephrology
Westminster, Colorado, 80031, United States
Pines Clinical Research, Inc.
Pembroke Pines, Florida, 33028, United States
Kidney Care Associates, LLC
Augusta, Georgia, 30901, United States
Circle Medical Management
Chicago, Illinois, 60607, United States
Western New England Renal & Transplant Associates
Springfield, Massachusetts, 01107, United States
Brookdale Physician's Dialysis Associates
Brooklyn, New York, 11212, United States
DCI
Cincinnati, Ohio, 45206, United States
Cleveland Clinical Foundation Fresenius East (Fairhill)
Cleveland, Ohio, 44104, United States
The Ohio State University Cramblett Medical Clinic
Columbus, Ohio, 43210, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, 37404, United States
Nephrology Associates, PC
Nashville, Tennessee, 37205, United States
Meharry Medical College Clinical Research Center
Nashville, Tennessee, 37208, United States
Vanderbilt University Medical Center Clinical Trials Center
Nashville, Tennessee, 37232-1371, United States
Kidney Associates
Houston, Texas, 77030, United States
Centre Point Dialysis
West Allis, Wisconsin, 53214, United States
RCMI- Clinical Research Center Medical Sciences Campus University of Puerto Rico
Rio Piedras, PR, 00936-5067, Puerto Rico
Related Publications (2)
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVEDDwyer JP, Sika M, Schulman G, Chang IJ, Anger M, Smith M, Kaplan M, Zeig S, Koury MJ, Blumenthal SS, Lewis JB; Collaborative Study Group. Dose-response and efficacy of ferric citrate to treat hyperphosphatemia in hemodialysis patients: a short-term randomized trial. Am J Kidney Dis. 2013 May;61(5):759-66. doi: 10.1053/j.ajkd.2012.11.041. Epub 2013 Jan 29.
PMID: 23369827DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information
- Organization
- Keryx Biopharmaceuticals Inc
Study Officials
- STUDY CHAIR
Julia B Lewis, MD
Collaborative Study Group (CSG)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2010
First Posted
February 24, 2010
Study Start
May 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
December 4, 2014
Results First Posted
December 4, 2014
Record last verified: 2014-12