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

Iron Deficiency Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736397
• Other study ID #: KRX-0502-204
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2012
• Last updated: September 20, 2017
• Start date: November 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2017
• Source: Keryx Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency
• Iron Deficiency Anemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Ferric Citrate
Dose depends on serum phosphorus levels collected at each study visit.
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Keryx Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 Weeks
Primary	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.	12 Weeks
Secondary	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.	12 Weeks
Secondary	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.	12 Weeks