Clinical Trial: 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)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official 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 Periton

Brief 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.


Detailed Summary:
Sponsor: Vifor Fresenius Medical Care Renal Pharma

Current Primary Outcome:

  • Incidence of Adverse Drug Reactions (ADRs) [ Time Frame: through study completion, up to 42 months ]
  • Proportion of Adverse Drug Reactions (ADRs) [ Time Frame: through study completion, up to 42 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Patient Reported Outcome questionnaire - Adherence to Velphoro based on the standard Morisky questionnaire [ Time Frame: through study completion, up to 42 months ]
    Patient reported outcomes will be evaluated by descriptive statistics
  • Patient Reported Outcome questionnaire - Perceived Pill based on the ACTG questionnaire [ Time Frame: through study completion, up to 42 months ]
    Patient reported outcomes will be evaluated by descriptive statistics
  • Patient Reported Outcome questionnaire - Treatment satisfaction based on the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) [ Time Frame: through study completion, up to 42 months ]
    Patient reported outcomes will be evaluated by descriptive statistics


Original Secondary Outcome: Same as current

Information By: Vifor Fresenius Medical Care Renal Pharma

Dates:
Date Received: February 9, 2016
Date Started: April 2016
Date Completion:
Last Updated: July 7, 2016
Last Verified: July 2016