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)

• Status: Completed
• Trial end date: 2019-04-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vifor Fresenius Medical Care Renal Pharma

Criteria

Inclusion Criteria:

• Age ≥18 years

• Signed informed consent

• Indication for Velphoro treatment in accordance with the SmPC

• Prevalent dialysis patients with a dialysis vintage of at least 6 months (HD or PD)

• Treatment-naïve or pre-treated with anti-hyperphosphataemic therapy

Exclusion Criteria:

• Prior participation in this NIS (Non-Interventional Study)

• Parallel participation in an interventional study

• Enrolment in a prior clinical trial with Velphoro