A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
NCT ID: NCT01324128
Last Updated: 2014-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1059 participants
INTERVENTIONAL
2011-03-31
2012-10-31
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
NONE
Study Groups
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PA21 (2.5 g tablet)
PA21 (2.5 g tablet containing 500 mg iron)
Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
Sevelamer carbonate
Sevelamer carbonate
Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)
PA21-1 (1.25 g tablet)
PA21-1 (1.25 g tablet containing 250 mg iron)
Low dose comparator (1.25 g/day)
Interventions
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PA21 (2.5 g tablet containing 500 mg iron)
Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
Sevelamer carbonate
Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)
PA21-1 (1.25 g tablet containing 250 mg iron)
Low dose comparator (1.25 g/day)
Eligibility Criteria
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Inclusion Criteria
* Stable dose of phosphate binder
* Written informed consent
Exclusion Criteria
* Other significant medical conditions
* Pregnancy
18 Years
ALL
No
Sponsors
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Fresenius Medical Care North America
INDUSTRY
Vifor Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Juergen Floege, MD
Role: PRINCIPAL_INVESTIGATOR
Medizinische Klinik II
Locations
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San Antonio, Texas, United States
LKH St. Polten
Sankt Pölten, , Austria
CHU Sart Tilman
Liège, , Belgium
Clinical Hospital Center Rijeka
Rijeka, , Croatia
Dialysis Centre Fresenius Medical Care
Sokolov, , Czechia
KfH Nierenzentrum Berlin-Neukoelln
Berlin, , Germany
Vidzemes Hospital
Valmiera, , Latvia
Vilnius University Hospital Santariskiu Clinics
Vilnius, , Lithuania
Teaching Hospital no.1 of Medical University of Lodz
Lodz, , Poland
Dialmed Clinic SRL
Sibiu, , Romania
City Mariinsky Hospital
Saint Petersburg, , Russia
Zvezdara Clinical Medical Center
Belgrade, , Serbia
Lakeview Hospital
Benoni, , South Africa
Mykolayiv Regional Hospital
Mykolayiv, , Ukraine
Dorset County Hospital NHS Foundation Trust
Dorset, , United Kingdom
Countries
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References
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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.
Sprague SM, Ketteler M, Covic AC, Floege J, Rakov V, Walpen S, Rastogi A. Long-term efficacy and safety of sucroferric oxyhydroxide in African American dialysis patients. Hemodial Int. 2018 Oct;22(4):480-491. doi: 10.1111/hdi.12663. Epub 2018 Apr 15.
Other Identifiers
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PA-CL-05A
Identifier Type: -
Identifier Source: org_study_id
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