VERIFIE (Velphoro Evaluation of Real-lIfe saFety, effectIveness and adherencE): 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

Study identification

• EU PAS number:
  EUPAS11502
• Study ID:
  35019
• Official title and acronym:
  VERIFIE (Velphoro Evaluation of Real-lIfe saFety, effectIveness and adherencE): 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
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Greece

  Italy

  Netherlands

  Spain

  United Kingdom
• Study description:
  The new 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. Velphoro has been approved by the European Medicines Agency (EMA) (August 2014). The approved indication in the European Union (EU) is to control sP levels in adult CKD patients on HD or PD. Experience to date in the use of Velphoro results from more than 1,100 patients who have participated in clinical trials. During clinical trials, the most common side effects included gastrointestinal (GI) disorders (mostly diarrhoea and stool discolouration) and abnormal product taste. The majority of GI disorders occurred early during treatment and receded with continued drug application.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 this non-interventional study to investigate short and long-term (beyond 1 year) safety, including GI effects, potential masking of GI bleedings due to stool discolouration, and the risk of iron accumulation. Evaluation of PD patients is of special interest, since their numbers have been limited within the clinical trials.Furthermore, effectiveness and treatment adherence during real-life use will be evaluated.
• Study status:
  Finalised

Research institutions and networks

Institutions

Vifor Fresenius Medical Care Renal Pharma France

Multiple centres: 178 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:30/09/2015

Actual:30/09/2015

Study start date

Planned:29/01/2016

Actual:06/04/2016

Data analysis start date

Planned:06/04/2019

Actual:14/06/2019

Date of interim report, if expected

Planned:26/07/2018

Actual:26/07/2018

Date of final study report

Planned:31/12/2019

Actual:16/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Vifor Fresenius Medical Care Renal Pharma France

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)