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

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:

MedlinePlus related topics: Anemia Chronic Kidney Disease Dialysis Iron

Drug Information available for: Sodium citrate Phosphorus

U.S. FDA Resources

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 ]

Estimated Enrollment:	150
Study Start Date:	November 2012
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736397

Contacts

Contact: Shay Shemesh, MS		sshemesh@keryx.com
Contact: Carolyn Connelly		cconnelly@keryx.com

Locations

United States, Arizona
	Withdrawn
Phoenix, Arizona, United States
	Recruiting
Tempe, Arizona, United States
United States, California
	Recruiting
La Mesa, California, United States
United States, Colorado
	Recruiting
Denver, Colorado, United States
United States, Florida
	Recruiting
Edgewater, Florida, United States
	Recruiting
Miami, Florida, United States
	Withdrawn
Ocala, Florida, United States
United States, Idaho
	Recruiting
Meridian, Idaho, United States
United States, Illinois
	Recruiting
Evergreen Park, Illinois, United States
United States, Maryland
	Recruiting
Bethesda, Maryland, United States
United States, Massachusetts
	Recruiting
Springfield, Massachusetts, United States
United States, Michigan
	Recruiting
Detroit, Michigan, United States
United States, Nevada
	Recruiting
Reno, Nevada, United States
United States, New York
	Recruiting
Great Neck, New York, United States
	Recruiting
Mineola, New York, United States
	Withdrawn
Orchard Park, New York, United States
United States, North Carolina
	Recruiting
Asheville, North Carolina, United States
	Recruiting
Wilmington, North Carolina, United States
United States, South Carolina
	Withdrawn
Orangeburg, South Carolina, United States
United States, Texas
	Recruiting
Houston, Texas, United States
	Recruiting
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:	May 16, 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
Kidney Diseases
Deficiency Diseases
Anemia, Iron-Deficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic

Iron Metabolism Disorders
Metabolic Diseases
Renal Insufficiency
Citric Acid
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013