Clinical trial NCT01736397: Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Iron Deficiency
Iron Deficiency Anemia
Keywords: CKD
Chronic Kidney Disease
Phosphorus
Iron Deficiency
Iron Deficiency Anemia
Elevated Phosphorus
Lead sponsor: Keryx Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment
timeFrame: 12 Weeks
measure: Change in Serum Phosphorus Levels From Baseline to End of Treatment
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change in Ferritin Levels From Baseline to End of Treatment
timeFrame: 12 Weeks
measure: Change in Hemoglobin Levels From Baseline to End of Treatment
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Tempe
country: United States
state: Arizona
city: La Mesa
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Edgewater
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Meridian
country: United States
state: Idaho
city: Evergreen Park
country: United States
state: Illinois
city: Bethesda
country: United States
state: Maryland
city: Springfield
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Pontiac
country: United States
state: Michigan
city: Reno
country: United States
state: Nevada
city: Great Neck
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Orangeburg
country: United States
state: South Carolina
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
name: Geoffrey Block, MD
role: STUDY_CHAIR
name: Glenn Chertow, MD
role: STUDY_CHAIR
name: Steven Fishbane, MD
role: STUDY_CHAIR
References:
citation: Block GA, Fishbane S, Rodriguez M, Smits G, Shemesh S, Pergola PE, Wolf M, Chertow GM. A 12-week, double-blind, placebo-controlled trial of ferric citrate for the treatment of iron deficiency anemia and reduction of serum phosphate in patients with CKD Stages 3-5. Am J Kidney Dis. 2015 May;65(5):728-36. doi: 10.1053/j.ajkd.2014.10.014. Epub 2014 Nov 4.