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Clinical Trial Details

Trial ID: L0689
Source ID: NCT01464190
Associated Drug: Pa21 (2.5 G Tablet Containing 500 Mg Iron)
Title: A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01464190/results
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Interventions: DRUG: PA21 (2.5 g tablet containing 500 mg iron)|DRUG: Sevelamer carbonate
Outcome Measures: Primary: Change From Baseline and Levels at Each Time Point for Serum Phosphorus, Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing., Every 4 weeks from baseline to Week 28|Change From Baseline and Levels at Each Time Point for Serum Calcium, Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing., Every 4 weeks from baseline to Week 28|Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH), Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing., Every 4 weeks from baseline to Week 28 |
Sponsor/Collaborators: Sponsor: Vifor Pharma | Collaborators: Fresenius Medical Care North America
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 659
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-09
Completion Date: 2013-04
Results First Posted: 2014-02-17
Last Update Posted: 2014-04-01
Locations: San Antonio, Texas, 78215, United States|Medizinische Abteilung Nephrologie und Dialyse, St. Pölten, 3100, Austria|CHU Sart Tilman, Liege, 4000, Belgium|Clinical Hospital Center Rijeka, Rijeka, 51000, Croatia|Hospital with Polyclinic Novy Jicin, Novy Jicin, 74101, Czech Republic|KfH Nierenzentrum Berlin-Neukoelln, Berlin, 12045, Germany|Vidzemes Hospital, Valmiera, LV-4201, Latvia|JSC "Diaverum Clinics", Klaipeda, LT-93220, Lithuania|Teaching Hospital no.1 of Medical University of Lodz, Lodz, 90-153, Poland|Dialmed Clinic SRL, Sibiu, 550135, Romania|Kemerovo Regional hospital, Kemerovo, 650029, Russian Federation|Zvezdara Clinical Medical Center, Belgrade, 11000, Serbia|St Augustines Hospital, Durban, 4001, South Africa|Mykolayiv Regional Hospital, Mykolayiv, 54058, Ukraine|Dorset County Hospital NHS Foundation Trust, Dorset, DT1 2JY, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01464190

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress