Hyperphosphatemia
Conditions
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.
Interventions
DRUGsucroferric 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.
Sponsors
Vifor Fresenius Medical Care Renal Pharma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Prior participation in this NIS (Non-Interventional Study) * Parallel participation in an interventional study * Enrolment in a prior clinical trial with Velphoro
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed