A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease

December 3, 2014 updated by: Keryx Biopharmaceuticals

A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) Following a Two-Week Washout Period

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There will be a screening visit about 4 weeks receiving study drug. Upon qualifying for the study after the screening visit, patients will then be asked to stop taking their current phosphate binder for about 2 weeks. Then, if patients continue to qualify for the study, they will be entered in the study that lasts about 28 days. Study visits will happen every week during the patient's usual dialysis appointments. There will be a total of up to 9 visits for this study, and total participation time could last up to 8 weeks.

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00936-5067
        • RCMI- Clinical Research Center Medical Sciences Campus University of Puerto Rico
  • United States
    • Colorado
      • Westminster, Colorado, United States, 80031
        • Western Nephrology
    • Florida
      • Pembroke Pines, Florida, United States, 33028
        • Pines Clinical Research, Inc.
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Kidney Care Associates, LLC
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Circle Medical Management
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Western new England Renal & Transplant Associates
    • New York
      • Brooklyn, New York, United States, 11212
        • Brookdale Physician's Dialysis Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • DCI
      • Cleveland, Ohio, United States, 44104
        • Cleveland Clinical Foundation Fresenius East (Fairhill)
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Cramblett Medical Clinic
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Southeast Renal Research Institute
      • Nashville, Tennessee, United States, 37205
        • Nephrology Associates, PC
      • Nashville, Tennessee, United States, 37208
        • Meharry Medical College Clinical Research Center
      • Nashville, Tennessee, United States, 37232-1371
        • Vanderbilt University Medical Center Clinical Trials Center
    • Texas
      • Houston, Texas, United States, 77030
        • Kidney Associates
    • Wisconsin
      • West Allis, Wisconsin, United States, 53214
        • Centre Point Dialysis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Unsuitable for this trial per Principal Investigator's clinical judgment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 g/day
1 g/day KRX-0502 (ferric citrate)
Drug: ferric citrate
1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days
Other Names:
  • KRX-0502
Experimental: 6 g/day
6 g/day KRX-0502 (ferric citrate)
Drug: ferric citrate
1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days
Other Names:
  • KRX-0502
Experimental: 8 g/day
8 g/day KRX-0502 (ferric citrate)
Drug: ferric citrate
1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days
Other Names:
  • KRX-0502

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum Phosphorus From Baseline to End of Treatment
Time Frame: Baseline and day 28
Mean change from baseline was calculated separately for each treatment arm (LOCF)
Baseline and day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pairwise Comparison of the Mean Change in Serum Phosphorus From Baseline to the End of Treatment
Time Frame: Baseline and day 28
Mean change from baseline was calculated separately for each treatment arm. Only subjects that have both baseline and end of treatment serum phosphorus scores were analyzed for this outcome.
Baseline and day 28
Proportion of Patient With a Serum Phosphorus ≤5.5 mg/dL at the End of Treatment
Time Frame: Baseline and day 28
proportion was calculated separately for each treatment arm
Baseline and day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keryx Biopharmaceuticals

Collaborators

Collaborative Study Group (CSG)

Investigators

  • Study Chair: Julia B Lewis, MD, Collaborative Study Group (CSG)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 17, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRX-0502-305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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