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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01736397
First Posted: November 29, 2012
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Keryx Biopharmaceuticals
  Purpose
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.

Condition Intervention Phase
Iron Deficiency Iron Deficiency Anemia Drug: Ferric Citrate Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Keryx Biopharmaceuticals:

Primary Outcome Measures:
  • 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.

  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.


Enrollment: 149
Study Start Date: November 2012
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736397


Locations
United States, Arizona
Tempe, Arizona, United States
United States, California
La Mesa, California, United States
Sacramento, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Florida
Edgewater, Florida, United States
Miami, Florida, United States
United States, Idaho
Meridian, Idaho, United States
United States, Illinois
Evergreen Park, Illinois, United States
United States, Maryland
Bethesda, Maryland, United States
United States, Massachusetts
Springfield, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
Pontiac, Michigan, United States
United States, Nevada
Reno, Nevada, United States
United States, New York
Great Neck, New York, United States
Mineola, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
Wilmington, North Carolina, United States
United States, South Carolina
Orangeburg, South Carolina, United States
United States, Texas
Houston, Texas, United States
San Antonio, Texas, United States
Sponsors and Collaborators
Keryx Biopharmaceuticals
Investigators
Study Chair: Geoffrey Block, MD
Study Chair: Glenn Chertow, MD
Study Chair: Steven Fishbane, MD
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01736397     History of Changes
Other Study ID Numbers: KRX-0502-204
First Submitted: November 16, 2012
First Posted: November 29, 2012
Results First Submitted: August 17, 2017
Results First Posted: October 20, 2017
Last Update Posted: October 20, 2017
Last Verified: September 2017

Keywords provided by Keryx Biopharmaceuticals:
CKD
Chronic Kidney Disease
Phosphorus
Iron Deficiency
Iron Deficiency Anemia
Elevated Phosphorus

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Anemia, Iron-Deficiency
Urologic Diseases
Renal Insufficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Citric Acid
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Hematinics