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

Keryx Biopharmaceuticals149 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

149

Conditions

Iron Deficiency Iron Deficiency Anemia

Interventions

Ferric CitrateDRUG

Dose depends on serum phosphorus levels collected at each study visit.

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Unnamed facility

Tempe, Arizona, United States

Unnamed facility

La Mesa, California, United States

Unnamed facility

Sacramento, California, United States

Outcomes

Primary Outcomes

Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment

The difference in TSAT between the value at the end of treatment (week 12) minus the baseline measurement.

Time frame: 12 Weeks

Change in Serum Phosphorus Levels From Baseline to End of Treatment

The difference in serum phosphorus between the value at the end of treatment (week 12) minus the baseline measurement.

Time frame: 12 Weeks

Secondary Outcomes

Change in Ferritin Levels From Baseline to End of Treatment

The difference in ferritin levels between the value at the end of treatment (week 12) minus the baseline measurement.

Time frame: 12 Weeks

Change in Hemoglobin Levels From Baseline to End of Treatment

The difference in hemoglobin levels between the value at the end of treatment (week 12) minus the baseline measurement.

Time frame: 12 Weeks

Data from ClinicalTrials.gov

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