VERIFIE
Research type
Research Study
Full title
Non-interventional Study to Investigate the Short and Long-term Real-life Safety, Effectiveness, and Adherence of Velphoro® in Patients with Hyperphosphataemia Undergoing Haemodialysis or Peritoneal Dialysis
IRAS ID
213987
Contact name
Philip Kalra
Contact email
Sponsor organisation
Fresenius Medical Care Deutschland GmbH
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
This study is a non-interventional, prospective, multicentre, multinational (European), cohort study.
It is planned to enrol 1,000 patients who meet the inclusion criteria, and to whom none of the exclusion criteria apply who are being treated with Velphoro according to label (Summary of Product Characteristics (SmPC)) in approximately 8 European countries. There will be 10 to 50 study centres per country each recruiting around 5 patients.
Patients newly prescribed Velphoro (Velphoro-naïve patients), as well as those that have been treated with Velphoro in the past 6 months prior to study entry (Velphoro pre-treated patients) are eligible for this study. The scheduled study duration is 3 years, with a recruitment phase of 2 years. The minimum prospective observation period under Velphoro will be 12 months per patient and the maximum prospective observation period under Velphoro will be up to 36 months per patient after study start. In addition to the prospective data collection, retrospective data covering a period of 6 months prior to Velphoro treatment start and up to 6 months Velphoro treatment at the time of inclusion into the study (Velphoro pre-treated patients) will be documented. The whole observation period includes a period of 6 months prior to Velphoro treatment start and up to 36 months Velphoro treatment in Velphoronaïve patients and up to 42 months of Velphoro treatment in pre-treated patients (i.e. patients pre-treated with Velphoro for more than 3 months and up to 6 months).
Data will be collected at: initial visit, baseline (i.e., start of Velphoro treatment) and at Months 1, 3, 6 (may be documented retrospectively for Velphoro pre-treated patients), 12, 18, 24, 30, 36, and 42 (optional for patients pre-treated with Velphoro for more than 3 months and up to 6 months) after Velphoro treatment start.
REC name
London - City & East Research Ethics Committee
REC reference
16/LO/2091
Date of REC Opinion
4 Jan 2017
REC opinion
Further Information Favourable Opinion