Clinical trial NCT02687594: 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)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperphosphatemia
Lead sponsor: Vifor Fresenius Medical Care Renal Pharma
Sponsor class: INDUSTRY
First posted: 2016-02-22
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Drug Reactions (ADRs)
timeFrame: through study completion, up to 42 months
measure: Proportion of Adverse Drug Reactions (ADRs)
timeFrame: through study completion, up to 42 months
Secondary outcomes:
measure: Patient Reported Outcome questionnaire - Adherence to Velphoro based on the standard Morisky questionnaire
timeFrame: through study completion, up to 42 months
measure: Patient Reported Outcome questionnaire - Perceived Pill based on the ACTG questionnaire
timeFrame: through study completion, up to 42 months
measure: Patient Reported Outcome questionnaire - Treatment satisfaction based on the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9)
timeFrame: through study completion, up to 42 months
Other outcomes:
Locations:
city: Pierre Benite
country: France
facility: Centre Hospitalier LYON-SUD
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Athens
country: Greece
facility: General Hospital of Athens Laiko
city: Milano
country: Italy
facility: Ospedale Maggiore Policlinico
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Manchester
country: United Kingdom
facility: Salford Royal Hospitals NHS Trust
Study officials:
affiliation: Vifor Fresenius Medical Care Renal Pharma
name: Sebastian Walpen, Dr.
role: STUDY_CHAIR
References: