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

End Stage Renal Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Definitive Phase III Study of the Effects of Ferric Citrate on Serum Phosphate in Subjects With End Stage Renal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503736
• Other study ID #: PNC00301
• Status: Completed
• Phase: Phase 3
• Start date: June 2010

Study information

• Verified date: January 2020
• Source: Panion & BF Biotech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• ESRD
• Hyperphosphatemia
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• ferric citrate
0g/day ferric citrate capsule, TID for 56 days
• ferric citrate
4g/day ferric citrate capsule, TID for 56 days
• ferric citrate
6 g/day ferric citrate capsule, TID for 56 days

Locations

Country	Name	City	State
Taiwan	Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital	Kaohsiung
Taiwan	Division of Nephrology, Keelung Chang Gung Memorial Hospital	Keelung
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, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Panion & BF Biotech Inc.

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Lee CT, Wu IW, Chiang SS, Peng YS, Shu KH, Wu MJ, Wu MS. Effect of oral ferric citrate on serum phosphorus in hemodialysis patients: multicenter, randomized, double-blind, placebo-controlled study. J Nephrol. 2015 Feb;28(1):105-13. doi: 10.1007/s40620-014 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum phosphorus at Day 56 as compared to baseline		Day 56
Secondary	Change in serum phosphorus at Day 28 as compared to baseline		Day 28
Secondary	Change in Ca x P product at Day 56 compared to baseline		Day 56
Secondary	Change in Ca x P product at Day 28 compared to baseline		Day 28
Secondary	Cumulative drop out rate due to serum phosphorus concentration >9mg/dL at Day 56		Day 56
Secondary	Cumulative drop out rate due to serum Phosphorus concentration >9mg/dL at Day 28		Day 28