Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single group | sucroferric oxyhydroxide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sucroferric oxyhydroxide | Drug | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Male or female patients with a diagnosis of hyperphosphataemia who are due to be treated with Velphoro according to the product's Summary of Product Characteristics (SmPC) are eligible for this non-interventional study.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sebastian Walpen, Dr. | Vifor Fresenius Medical Care Renal Pharma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier LYON-SUD | Pierre-Bénite | 69495 | France | |||
| Klinikum Coburg |
Not provided
Not provided
Not provided
Not provided
|
|
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 |
| Coburg |
| 96450 |
| Germany |
| General Hospital of Athens Laiko | Athens | Greece |
| Ospedale Maggiore Policlinico | Milan | Italy |
| VU University Medical Center | Amsterdam | 1007 MB | Netherlands |
| Hospital Universitario Marqués de Valdecilla | Santander | Spain |
| Salford Royal Hospitals NHS Trust | Manchester | United Kingdom |
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000599459 | sucroferric oxyhydroxide |
Not provided
Not provided
Not provided