Trials / Completed

CompletedNCT02687594

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
Phase: —
Study type: Observational
Enrollment: 1,400 (actual)

Sponsor: Vifor Fresenius Medical Care Renal Pharma · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Hyperphosphatemia

Interventions

Type	Name	Description
DRUG	sucroferric oxyhydroxide	The non-interventional design allows the observation of patients in a broad range of settings reflecting routine clinical practice. All decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the full discretion of the treating physician without interference by a sponsor or study protocol. All treatment decisions will follow the real-life treatment behaviour.

Timeline

Start date: 2016-04-06
Primary completion: 2019-04-06
Completion: 2019-04-06
First posted: 2016-02-22
Last updated: 2019-10-01

Locations

7 sites across 7 countries: France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom

Source: ClinicalTrials.gov record NCT02687594. Inclusion in this directory is not an endorsement.