CLINICAL TRIALS PROFILE FOR SUCROFERRIC OXYHYDROXIDE
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All Clinical Trials for sucroferric oxyhydroxide
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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NCT02687594 ↗ | Non-interventional Study to Investigate the Short and Long Term Real-life Safety, Effectiveness, and Adherence of Velphoro® in Patients With Hyperphosphataemia Undergoing Haemodialysis (HD) or Peritoneal Dialysis (PD) | Completed | Vifor Fresenius Medical Care Renal Pharma | 2016-04-06 | An oral highly potent P binder Velphoro is a mixture of polynuclear iron(III) oxyhydroxide, sucrose, and starches. It was well tolerated in the clinical development program. The approved indication in the European Union (EU) is to control serums phosphorus (sP) levels in adult CKD (Chronic kidney disease) patients on HD (Haemodialysis) or PD (Peritoneal dialysis). It is of major interest to observe the drug in daily use outside of controlled trial settings. The Marketing Authorisation Holder wishes to obtain further systematic data within a non-interventional study to investigate short and long-term safety. Effectiveness and Treatment adherence during real-life use will be evaluated. | |
NCT02688764 ↗ | A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia | Terminated | Vifor Fresenius Medical Care Renal Pharma | Phase 3 | 2016-05-26 | This is a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients with Hyperphosphataemia. The aim of this Phase 3 clinical study is to demonstrate similar efficacy of PA21 (Velphoro) in paediatric and adolescent patients with CKD, and to provide safety and dosing information for this patient population. The Phoslyra (comparator) group provides information for a descriptive comparison of PA21 against a commonly used calcium-based phosphate binder (calcium acetate). |
NCT03010072 ↗ | The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum | Completed | Vifor Fresenius Medical Care Renal Pharma | Phase 2 | 2017-06-09 | This is a single-center, prospective, open-label, controlled, randomized, cross-over study in 34 prevalent end-stage renal disease patients on chronic hemodialysis treatment with hyperphosphatemia. |
NCT03010072 ↗ | The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum | Completed | Prim. Priv. Doz. Dr. Daniel Cejka | Phase 2 | 2017-06-09 | This is a single-center, prospective, open-label, controlled, randomized, cross-over study in 34 prevalent end-stage renal disease patients on chronic hemodialysis treatment with hyperphosphatemia. |
NCT03644264 ↗ | PA21 Safety and Efficacy in Adult Chinese Subjects | Completed | Vifor Fresenius Medical Care Renal Pharma | Phase 3 | 2018-08-31 | This study evaluates the efficacy of PA21 in comparison with sevelamer carbonate (Renvela®) in lowering and maintaining serum phosphorus in adult Chinese subjects with CKD on dialysis after 12 weeks of treatment. |
NCT03824587 ↗ | Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy | Completed | Ardelyx | Phase 2/Phase 3 | 2019-02-28 | This is a randomized, double-blind, placebo-controlled study to evaluate the effect of tenapanor on change in s-P levels when tenapanor is administered orally, twice daily for 28 days as adjunctive therapy to ESRD subjects with hyperphosphatemia on stable phosphate binder therapy. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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