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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hyperphosphatemia

Intervention / Treatment
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* Drug: sucroferric oxyhydroxide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| single group<br>sucroferric oxyhydroxide | Drug: sucroferric oxyhydroxide<br>* 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.<br>* Other names: PA21 (Velphoro);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

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