VERIFIE: 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 Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| single group sucroferric oxyhydroxide |
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 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 - Perceived Pill based on the ACTG 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years
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Signed informed consent
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Indication for Velphoro treatment in accordance with the SmPC
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Prevalent dialysis patients with a dialysis vintage of at least 6 months (HD or PD)
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Treatment-naïve or pre-treated with anti-hyperphosphataemic therapy
Exclusion Criteria:
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Prior participation in this NIS (Non-Interventional Study)
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Parallel participation in an interventional study
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Enrolment in a prior clinical trial with Velphoro
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier LYON-SUD | Pierre Benite | France | 69495 | |
| 2 | Klinikum Coburg | Coburg | Germany | 96450 | |
| 3 | General Hospital of Athens Laiko | Athens | Greece | ||
| 4 | Ospedale Maggiore Policlinico | Milano | Italy | ||
| 5 | VU University Medical Center | Amsterdam | Netherlands | 1007 MB | |
| 6 | Hospital Universitario Marqués de Valdecilla | Santander | Spain | ||
| 7 | Salford Royal Hospitals NHS Trust | Manchester | United Kingdom |
Sponsors and Collaborators
- Vifor Fresenius Medical Care Renal Pharma
Investigators
- Study Chair: Sebastian Walpen, Dr., Vifor Fresenius Medical Care Renal Pharma
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VFMCRP-MEAF-PA21-01-EU