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)
- Registration Number
- NCT02687594
- Lead Sponsor
- Vifor Fresenius Medical Care Renal Pharma
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1400
- 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
- Prior participation in this NIS (Non-Interventional Study)
- Parallel participation in an interventional study
- Enrolment in a prior clinical trial with Velphoro
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description single group sucroferric oxyhydroxide sucroferric oxyhydroxide
- Primary Outcome Measures
Name Time Method Incidence of Adverse Drug Reactions (ADRs) through study completion, up to 42 months Proportion of Adverse Drug Reactions (ADRs) through study completion, up to 42 months
- Secondary Outcome Measures
Name Time Method Patient Reported Outcome questionnaire - Adherence to Velphoro based on the standard Morisky questionnaire 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) 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 through study completion, up to 42 months Patient reported outcomes will be evaluated by descriptive statistics
Trial Locations
- Locations (7)
Centre Hospitalier LYON-SUD
🇫🇷Pierre Benite, France
Klinikum Coburg
🇩🇪Coburg, Germany
Salford Royal Hospitals NHS Trust
🇬🇧Manchester, United Kingdom
General Hospital of Athens Laiko
🇬🇷Athens, Greece
Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
VU University Medical Center
🇳🇱Amsterdam, Netherlands
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain