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.
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).
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.
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