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)

NCT02687594 | Completed DMC

• 1 other identifier: VFMCRP-MEAF-PA21-01-EU
• Study Type: observational
• Target: 1,400
• Locations: 7 countries
• Sites: 7

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.

Conditions

Hyperphosphatemia

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Patient Reported Outcome questionnaire - Adherence to Velphoro based on the standard Morisky questionnaire

  through study completion, up to 42 months

• Patient Reported Outcome questionnaire - Perceived Pill based on the ACTG questionnaire

  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)

  through study completion, up to 42 months

Study Arms (1)

single group

sucroferric oxyhydroxide

Drug: sucroferric oxyhydroxide

Interventions

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.

Also known as: PA21 (Velphoro)

single group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Prior participation in this NIS (Non-Interventional Study)
• Parallel participation in an interventional study
• Enrolment in a prior clinical trial with Velphoro

Sponsors & Collaborators

• Vifor Fresenius Medical Care Renal Pharma: lead

Study Sites (7)

Centre Hospitalier LYON-SUD

Pierre-Bénite, 69495, France

Location

Klinikum Coburg

Coburg, 96450, Germany

Location

General Hospital of Athens Laiko

Athens, Greece

Location

Ospedale Maggiore Policlinico

Milan, Italy

Location

VU University Medical Center

Amsterdam, 1007 MB, Netherlands

Location

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Location

Salford Royal Hospitals NHS Trust

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

sucroferric oxyhydroxide

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sebastian Walpen, Dr.

  Vifor Fresenius Medical Care Renal Pharma

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 22, 2016
• Study Start: April 6, 2016
• Primary Completion: April 6, 2019
• Study Completion: April 6, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

FR (1); NL (1); ES (1); GB (1); DE (1); GR (1); IT (1)