Back to resultsA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease
Primary Purpose
Hyperphosphatemia, End Stage Renal Disease, ESRD
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
ferric citrate
ferric citrate
ferric citrate
Sponsored by
About this trial
This is an interventional treatment trial for Hyperphosphatemia focused on measuring Kidney Diseases, Kidney Failure, Chronic, Hyperphosphatemia, Urologic Diseases, Renal Insufficiency, Chronic, Renal Insufficiency, Phosphorus Metabolism Disorders
Eligibility Criteria
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
Sites / Locations
- Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
- Division of Nephrology, Keelung Chang Gung Memorial Hospital
- Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
- Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital
- Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
4g/day
6g/day
Arm Description
Ferric Citrate for a total daily dose of 4g
Ferric Citrate for a total daily dose of 6g
Outcomes
Primary Outcome Measures
Change in serum phosphorus at Day 56 as compared to baseline
Secondary Outcome Measures
Change in serum phosphorus at Day 28 as compared to baseline
Change in Ca x P product at Day 56 compared to baseline
Change in Ca x P product at Day 28 compared to baseline
Cumulative drop out rate due to serum phosphorus concentration >9mg/dL at Day 56
Cumulative drop out rate due to serum Phosphorus concentration >9mg/dL at Day 28
Full Information
NCT ID
NCT01503736
First Posted
January 2, 2012
Last Updated
January 9, 2020
Sponsor
Panion & BF Biotech Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01503736
Brief Title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Panion & BF Biotech Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia, End Stage Renal Disease, ESRD
Keywords
Kidney Diseases, Kidney Failure, Chronic, Hyperphosphatemia, Urologic Diseases, Renal Insufficiency, Chronic, Renal Insufficiency, Phosphorus Metabolism Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
4g/day
Arm Type
Experimental
Arm Description
Ferric Citrate for a total daily dose of 4g
Arm Title
6g/day
Arm Type
Experimental
Arm Description
Ferric Citrate for a total daily dose of 6g
Intervention Type
Drug
Intervention Name(s)
ferric citrate
Intervention Description
0g/day ferric citrate capsule, TID for 56 days
Intervention Type
Drug
Intervention Name(s)
ferric citrate
Intervention Description
4g/day ferric citrate capsule, TID for 56 days
Intervention Type
Drug
Intervention Name(s)
ferric citrate
Intervention Description
6 g/day ferric citrate capsule, TID for 56 days
Primary Outcome Measure Information:
Title
Change in serum phosphorus at Day 56 as compared to baseline
Time Frame
Day 56
Secondary Outcome Measure Information:
Title
Change in serum phosphorus at Day 28 as compared to baseline
Time Frame
Day 28
Title
Change in Ca x P product at Day 56 compared to baseline
Time Frame
Day 56
Title
Change in Ca x P product at Day 28 compared to baseline
Time Frame
Day 28
Title
Cumulative drop out rate due to serum phosphorus concentration >9mg/dL at Day 56
Time Frame
Day 56
Title
Cumulative drop out rate due to serum Phosphorus concentration >9mg/dL at Day 28
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Division of Nephrology, Keelung Chang Gung Memorial Hospital
City
Keelung
Country
Taiwan
Facility Name
Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
City
New Taipei City
Country
Taiwan
Facility Name
Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24840781
Citation
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/s40620-014-0108-6. Epub 2014 May 20.
Results Reference
result
Learn more about this trial
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease
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