- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01503736
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
-
-
-
Kaohsiung, Taiwan
- Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
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Keelung, Taiwan
- Division of Nephrology, Keelung Chang Gung Memorial Hospital
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New Taipei City, Taiwan
- Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
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Taichung, Taiwan
- Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital
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Taipei, Taiwan
- Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital
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-
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
|
0g/day ferric citrate capsule, TID for 56 days
4g/day ferric citrate capsule, TID for 56 days
6 g/day ferric citrate capsule, TID for 56 days
|
Experimental: 4g/day
Ferric Citrate for a total daily dose of 4g
|
0g/day ferric citrate capsule, TID for 56 days
4g/day ferric citrate capsule, TID for 56 days
6 g/day ferric citrate capsule, TID for 56 days
|
Experimental: 6g/day
Ferric Citrate for a total daily dose of 6g
|
0g/day ferric citrate capsule, TID for 56 days
4g/day ferric citrate capsule, TID for 56 days
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
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.
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
- Metabolic Diseases
- Urologic Diseases
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Phosphorus Metabolism Disorders
- Kidney Diseases
- Kidney Failure, Chronic
- Hyperphosphatemia
- Molecular Mechanisms of Pharmacological Action
- Anticoagulants
- Hematinics
- Chelating Agents
- Sequestering Agents
- Calcium Chelating Agents
- Citric Acid
- Sodium Citrate
- Ferric Compounds
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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Clinical Trials on ferric citrate
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Keryx BiopharmaceuticalsCollaborative Study Group (CSG)CompletedHyperphosphatemia | End-stage Renal DiseaseUnited States
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Denver Nephrologists, P.C.Keryx BiopharmaceuticalsCompletedRenal Insufficiency | Chronic Kidney Disease | Iron Deficiency Anemia | HyperphosphatemiaUnited States
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Keryx BiopharmaceuticalsCompletedChronic Kidney Diseases | Iron Deficiency AnemiaUnited States
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University of California, Los AngelesNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingChronic Kidney DiseasesUnited States, Canada
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Keryx BiopharmaceuticalsCompletedHyperphosphatemia | End-stage Renal Disease | Renal Failure Chronic Requiring HemodialysisIsrael
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Keryx BiopharmaceuticalsCompletedAnemia of Chronic Kidney DiseaseIsrael