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.
Study Type
OBSERVATIONAL
Enrollment
1,400
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.
Centre Hospitalier LYON-SUD
Pierre-Bénite, France
Klinikum Coburg
Coburg, Germany
General Hospital of Athens Laiko
Athens, Greece
Ospedale Maggiore Policlinico
Milan, Italy
VU University Medical Center
Amsterdam, Netherlands
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Salford Royal Hospitals NHS Trust
Manchester, United Kingdom
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
Patient reported outcomes will be evaluated by descriptive statistics
Time frame: 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
Time frame: 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
Time frame: through study completion, up to 42 months
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