A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease
NCT ID: NCT01503736
Last Updated: 2020-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
183 participants
INTERVENTIONAL
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
ferric citrate
0g/day ferric citrate capsule, TID for 56 days
4g/day
Ferric Citrate for a total daily dose of 4g
ferric citrate
4g/day ferric citrate capsule, TID for 56 days
6g/day
Ferric Citrate for a total daily dose of 6g
ferric citrate
6 g/day ferric citrate capsule, TID for 56 days
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Panion & BF Biotech Inc.
INDUSTRY
Responsible Party
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Locations
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Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung City, , 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, , Taiwan
Countries
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References
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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.
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
Other Identifiers
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PNC00301
Identifier Type: -
Identifier Source: org_study_id
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