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) (VERIFIE)
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|ClinicalTrials.gov Identifier: NCT02687594|
Recruitment Status : Active, not recruiting
First Posted : February 22, 2016
Last Update Posted : October 15, 2018
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|
|Hyperphosphatemia||Drug: sucroferric oxyhydroxide|
|Study Type :||Observational|
|Actual Enrollment :||1400 participants|
|Official Title:||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|
|Actual Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
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 Name: PA21 (Velphoro)
- Incidence of Adverse Drug Reactions (ADRs) [ Time Frame: through study completion, up to 42 months ]
- Proportion of Adverse Drug Reactions (ADRs) [ Time Frame: through study completion, up to 42 months ]
- Patient Reported Outcome questionnaire - Adherence to Velphoro based on the standard Morisky questionnaire [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: through study completion, up to 42 months ]Patient reported outcomes will be evaluated by descriptive statistics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687594
|Centre Hospitalier LYON-SUD|
|Pierre Benite, France, 69495|
|Coburg, Germany, 96450|
|General Hospital of Athens Laiko|
|Ospedale Maggiore Policlinico|
|VU University Medical Center|
|Amsterdam, Netherlands, 1007 MB|
|Hospital Universitario Marqués de Valdecilla|
|Salford Royal Hospitals NHS Trust|
|Manchester, United Kingdom|
|Study Chair:||Sebastian Walpen, Dr.||Vifor Fresenius Medical Care Renal Pharma|