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

Keryx Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Iron Deficiency Anemia; Iron Deficiency

Treatments: Drug: Placebo; Drug: Ferric Citrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01736397

KRX-0502-204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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149 participants in 2 patient groups, including a placebo group

Ferric Citrate

Experimental group

Description:

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.

Treatment:

Drug: Ferric Citrate

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo