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Last Updated: January 27, 2023

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
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.
NCT04046263 ↗ Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients Completed University of Colorado, Denver Phase 4 2020-02-01 Prospective pilot study to determine if changing the phosphate binder to sucroferric oxyhydroxide for for 6 months improves disordered mineral metabolism and nutrition status in peritoneal dialysis patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sucroferric Oxyhydroxide

Condition Name

Condition Name for Sucroferric Oxyhydroxide
Intervention Trials
Hyperphosphatemia 5
Peritoneal Dialysis Complication 1
Chronic Kidney Disease Requiring Chronic Dialysis 1
Endstage Renal Disease 1
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Condition MeSH

Condition MeSH for Sucroferric Oxyhydroxide
Intervention Trials
Hyperphosphatemia 5
Renal Insufficiency, Chronic 2
Hypoalbuminemia 1
Kidney Diseases 1
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Clinical Trial Locations for Sucroferric Oxyhydroxide

Trials by Country

Trials by Country for Sucroferric Oxyhydroxide
Location Trials
United States 40
Germany 2
France 2
United Kingdom 1
Russian Federation 1
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Trials by US State

Trials by US State for Sucroferric Oxyhydroxide
Location Trials
Texas 2
Michigan 2
Pennsylvania 2
Alabama 2
Georgia 2
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Clinical Trial Progress for Sucroferric Oxyhydroxide

Clinical Trial Phase

Clinical Trial Phase for Sucroferric Oxyhydroxide
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Sucroferric Oxyhydroxide
Clinical Trial Phase Trials
Completed 5
Terminated 1
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Clinical Trial Sponsors for Sucroferric Oxyhydroxide

Sponsor Name

Sponsor Name for Sucroferric Oxyhydroxide
Sponsor Trials
Vifor Fresenius Medical Care Renal Pharma 4
Prim. Priv. Doz. Dr. Daniel Cejka 1
Ardelyx 1
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Sponsor Type

Sponsor Type for Sucroferric Oxyhydroxide
Sponsor Trials
Industry 5
Other 2
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