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Clinical Trial Details

Trial ID: L0692
Source ID: NCT01324128
Associated Drug: Pa21 (2.5 G Tablet Containing 500 Mg Iron)
Title: A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01324128/results
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Interventions: DRUG: PA21 (2.5 g tablet containing 500 mg iron)|DRUG: Sevelamer carbonate|DRUG: PA21-1 (1.25 g tablet containing 250 mg iron)
Outcome Measures: Primary: Change in Serum Phosphorus Levels From Week 24 to Week 27, Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27, Week 24, Week 27 | Secondary: Change in Serum Phosphorus Levels From Baseline to Week 12, Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group., Week 12 post Baseline
Sponsor/Collaborators: Sponsor: Vifor Pharma | Collaborators: Fresenius Medical Care North America
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1059
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-03
Completion Date: 2012-10
Results First Posted: 2014-04-01
Last Update Posted: 2014-04-24
Locations: San Antonio, Texas, 78215, United States|LKH St. Polten, St. Polten, 3100, Austria|CHU Sart Tilman, Liege, 4000, Belgium|Clinical Hospital Center Rijeka, Rijeka, 51000, Croatia|Dialysis Centre Fresenius Medical Care, Sokolov, 35601, Czech Republic|KfH Nierenzentrum Berlin-Neukoelln, Berlin, 12045, Germany|Vidzemes Hospital, Valmiera, LV-4201, Latvia|Vilnius University Hospital Santariskiu Clinics, Vilnius, LT-08661, Lithuania|Teaching Hospital no.1 of Medical University of Lodz, Lodz, 90-153, Poland|Dialmed Clinic SRL, Sibiu, 550135, Romania|City Mariinsky Hospital, St. Petersburg, 191104, Russian Federation|Zvezdara Clinical Medical Center, Belgrade, 11000, Serbia|Lakeview Hospital, Benoni, 1500, South Africa|Mykolayiv Regional Hospital, Mykolayiv, 54058, Ukraine|Dorset County Hospital NHS Foundation Trust, Dorset, DT1 2JY, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01324128

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress