A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease

Phase 3

Completed

• Conditions: Hyperphosphatemia; End Stage Renal Disease; ESRD
• Interventions: Drug: ferric citrate

• Registration Number: NCT01503736
• Lead Sponsor: Panion & BF Biotech Inc.

Brief Summary

The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end stage renal disease (ESRD).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2012-01-02
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-04
• Primary Completion: 2012-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

• Age>18 years and has a diagnosis of ESRD
• On a three-times per week hemodialysis regimen
• On a stable dose of a phosphate-binding agent for at least one month prior to study entry.
• If on vitamin D supplementation or calcitriol, must be on a stable dose for at least one month prior to study entry.
• Hct >= 20%
• Serum Ca level of 8 mg/dL to 10.5 mg/dL

Exclusion Criteria

• Is pregnant or lactating
• Clinically significant GI disorder
• Has tertiary hyperparathyroidism or is immediately post-operative from a parathyroidectomy (within the first 3 months post-op or the plasma Ca is <7 mg/dL)
• ferritin>800 ng/mL
• Unstable medical condition unsuitable for the study in the opinion of investigator
• Has been treated with an investigational agent within 30 days of enrollment
• Has a history of documented iron allergy or hemochromatosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	ferric citrate	-
6g/day	ferric citrate	Ferric Citrate for a total daily dose of 6g
4g/day	ferric citrate	Ferric Citrate for a total daily dose of 4g

Primary Outcome Measures

Name	Time	Method
Change in serum phosphorus at Day 56 as compared to baseline	Day 56

Secondary Outcome Measures

Name	Time	Method
Change in Ca x P product at Day 56 compared to baseline	Day 56
Change in serum phosphorus at Day 28 as compared to baseline	Day 28
Change in Ca x P product at Day 28 compared to baseline	Day 28
Cumulative drop out rate due to serum phosphorus concentration >9mg/dL at Day 56	Day 56
Cumulative drop out rate due to serum Phosphorus concentration >9mg/dL at Day 28	Day 28

Trial Locations

Locations (5)

Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan

Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital; 🇨🇳 New Taipei City, Taiwan

Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Division of Nephrology, Keelung Chang Gung Memorial Hospital; 🇨🇳 Keelung, Taiwan