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

January 9, 2020 updated by: Panion & BF Biotech Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
      • Keelung, Taiwan
        • Division of Nephrology, Keelung Chang Gung Memorial Hospital
      • New Taipei City, Taiwan
        • Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
      • Taichung, Taiwan
        • Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital
      • Taipei, Taiwan
        • Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: ferric citrate
0g/day ferric citrate capsule, TID for 56 days
Drug: ferric citrate
4g/day ferric citrate capsule, TID for 56 days
Drug: ferric citrate
6 g/day ferric citrate capsule, TID for 56 days
Experimental: 4g/day
Ferric Citrate for a total daily dose of 4g
Drug: ferric citrate
0g/day ferric citrate capsule, TID for 56 days
Drug: ferric citrate
4g/day ferric citrate capsule, TID for 56 days
Drug: ferric citrate
6 g/day ferric citrate capsule, TID for 56 days
Experimental: 6g/day
Ferric Citrate for a total daily dose of 6g
Drug: ferric citrate
0g/day ferric citrate capsule, TID for 56 days
Drug: ferric citrate
4g/day ferric citrate capsule, TID for 56 days
Drug: ferric citrate
6 g/day ferric citrate capsule, TID for 56 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in serum phosphorus at Day 56 as compared to baseline
Time Frame: Day 56
Day 56

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Panion & BF Biotech Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

January 2, 2012

First Submitted That Met QC Criteria

January 3, 2012

First Posted (Estimate)

January 4, 2012

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNC00301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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