Status:
COMPLETED
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease
Lead Sponsor:
Panion & BF Biotech Inc.
Conditions:
Hyperphosphatemia
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT01503736
Start Date
June 1 2010
Last Update
January 13 2020
Active Locations (5)
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1
Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung City, Taiwan
2
Division of Nephrology, Keelung Chang Gung Memorial Hospital
Keelung, Taiwan
3
Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
New Taipei City, Taiwan
4
Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital
Taichung, Taiwan