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)

Hyperphosphatemia Clinical Trial

— VERIFIE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687594
• Other study ID #: VFMCRP-MEAF-PA21-01-EU
• Status: Completed
• Start date: April 6, 2016
• Est. completion date: April 6, 2019

Study information

• Verified date: September 2019
• Source: Vifor Fresenius Medical Care Renal Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: April 6, 2019
• Est. primary completion date: April 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier LYON-SUD	Pierre Benite
Germany	Klinikum Coburg	Coburg
Greece	General Hospital of Athens Laiko	Athens
Italy	Ospedale Maggiore Policlinico	Milano
Netherlands	VU University Medical Center	Amsterdam
Spain	Hospital Universitario Marqués de Valdecilla	Santander
United Kingdom	Salford Royal Hospitals NHS Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Vifor Fresenius Medical Care Renal Pharma

Countries where clinical trial is conducted

France,  Germany,  Greece,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Drug Reactions (ADRs)		through study completion, up to 42 months
Primary	Proportion of Adverse Drug Reactions (ADRs)		through study completion, up to 42 months
Secondary	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
Secondary	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
Secondary	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