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:
Information provided by (Responsible Party):
Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01736397
First received: November 16, 2012
Last updated: December 27, 2013
Last verified: December 2013
  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) subjects not on dialysis. Total length of treatment is approximately 12 weeks.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 TSAT (transferrin saturation) from baseline to end of treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in serum phosphorus levels from baseline to end of treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of adverse events overall and by organ system class, preferred term, severity, and suspected relationship to study drug by treatment assignment as a measure of safety and tolerability [ Time Frame: Approximately 16 weeks ] [ Designated as safety issue: Yes ]
    SAEs will be monitored for an additional 28 days after last study visit.

  • Type of concomitant medications used by treatment assignment as a measure of safety [ Time Frame: Approximately 16 weeks ] [ Designated as safety issue: Yes ]
  • Change in sequential blood chemistries by treatment assignment as a measure of safety [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Change in hemoglobin levels from baseline to end of treatment by treatment assignment as a measure of safety [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in ferritin levels from baseline to end of treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

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 dose of ferric citrate will depend on the patient'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
  • Zerenex
Placebo Comparator: Placebo
Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • 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
  • GI 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, IV 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01736397     History of Changes
Other Study ID Numbers: KRX-0502-204
Study First Received: November 16, 2012
Last Updated: December 27, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Malnutrition
Metabolic Diseases
Nutrition Disorders
Renal Insufficiency
Urologic Diseases
Citric Acid
Anticoagulants
Chelating Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sequestering Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014