Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis

September 20, 2017 updated by: Keryx Biopharmaceuticals

A Phase 2 Study of KRX-0502 (Ferric Citrate) in Managing Serum Phosphorus and Iron Deficiency in Anemic Subjects With Stage III to V Chronic Kidney Disease Not on Dialysis

The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic chronic kidney disease (CKD) stage 3-5 subjects not on dialysis. Total length of treatment is approximately 12 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, placebo-controlled, three-period, multi-center clinical trial. Following a Screening and Qualification Period and a two-week Washout Period (for those subjects entering the study on a phosphate binder), eligible subjects will be randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or placebo for up to approximately 12 weeks. The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic CKD subjects not on dialysis.

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Phase 2

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

  • United States
    • Arizona
      • Tempe, Arizona, United States
    • California
      • La Mesa, California, United States
      • Sacramento, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Edgewater, Florida, United States
      • Miami, Florida, United States
    • Idaho
      • Meridian, Idaho, United States
    • Illinois
      • Evergreen Park, Illinois, United States
    • Maryland
      • Bethesda, Maryland, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
      • Pontiac, Michigan, United States
    • Nevada
      • Reno, Nevada, United States
    • New York
      • Great Neck, New York, United States
      • Mineola, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Wilmington, North Carolina, United States
    • South Carolina
      • Orangeburg, South Carolina, United States
    • Texas
      • Houston, Texas, United States
      • San Antonio, Texas, United States

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:

  • Stage III to V Chronic Kidney Disease
  • Serum Phosphorus 4.0-6.0 mg/dL prior to Randomization
  • Ferritin 300 ng/mL or less
  • Transferrin Saturation (TSAT) 30% or less
  • Hemoglobin >9.0 and <12.0 g/dL
  • Must consume a minimum of 2 meals per day

Exclusion Criteria:

  • Parathyroidectomy within 24 weeks of study
  • gastrointestinal bleed or inflammatory bowel disease within 12 weeks of study
  • Requirement for dialysis or kidney injury within 8 weeks of study
  • Absolute requirement for oral iron, intravenous iron, Erythropoiesis-Stimulating Agent, blood transfusions, and Sensipar during the study
  • Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
  • Absolute requirement for vitamin C, niacin, or nicotinamide outside of multivitamins
  • History of hemochromatosis
  • Allergy to iron products
  • History of malignancy in last 5 years

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ferric Citrate
Ferric citrate will be taken with or within one hour of meals or snacks. The starting dose of ferric citrate is 3 tablets/day and titrated by the subject's serum phosphorus results at each treatment visit.
Drug: Ferric Citrate
Dose depends on serum phosphorus levels collected at each study visit.
Other Names:
  • KRX-0502
Placebo Comparator: Placebo
Placebo will be taken with or within one hour of meals or snacks. The starting dose of placebo is 3 tablets per day and titrated by the subject's serum phosphorus results at each treatment visit.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment
Time Frame: 12 Weeks
The difference in TSAT between the value at the end of treatment (week 12) minus the baseline measurement.
12 Weeks
Change in Serum Phosphorus Levels From Baseline to End of Treatment
Time Frame: 12 Weeks
The difference in serum phosphorus between the value at the end of treatment (week 12) minus the baseline measurement.
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Ferritin Levels From Baseline to End of Treatment
Time Frame: 12 Weeks
The difference in ferritin levels between the value at the end of treatment (week 12) minus the baseline measurement.
12 Weeks
Change in Hemoglobin Levels From Baseline to End of Treatment
Time Frame: 12 Weeks
The difference in hemoglobin levels between the value at the end of treatment (week 12) minus the baseline measurement.
12 Weeks

Collaborators and Investigators

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

Sponsor

Keryx Biopharmaceuticals

Investigators

  • Study Chair: Geoffrey Block, MD
  • Study Chair: Glenn Chertow, MD
  • Study Chair: Steven Fishbane, MD

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

November 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 16, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 29, 2012

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

September 20, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRX-0502-204

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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