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)

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

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 Overview

• Status: Completed
• Conditions: Hyperphosphatemia
• Intervention / Treatment: Drug: sucroferric oxyhydroxide

• Study Type: Observational
• Enrollment (Actual): 1400

Contacts and Locations

Study Locations

• France
  • Pierre Benite, France, 69495
    • Centre Hospitalier Lyon-Sud
• Germany
  • Coburg, Germany, 96450
    • Klinikum Coburg
• Greece
  • Athens, Greece
    • General Hospital of Athens Laiko
• Italy
  • Milano, Italy
    • Ospedale Maggiore Policlinico
• Netherlands
  • Amsterdam, Netherlands, 1007 MB
    • VU University Medical Center
• Spain
  • Santander, Spain
    • Hospital Universitario Marques de Valdecilla
• United Kingdom
  • Manchester, United Kingdom
    • Salford Royal Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

single group; sucroferric oxyhydroxide

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 Names: PA21 (Velphoro)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Vifor Fresenius Medical Care Renal Pharma
• Investigators: Study Chair: Sebastian Walpen, Dr., Vifor Fresenius Medical Care Renal Pharma

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2016
• Primary Completion (Actual): April 6, 2019
• Study Completion (Actual): April 6, 2019

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 16, 2016
• First Posted (Estimate): February 22, 2016

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hyperphosphatemia
• Other Study ID Numbers: VFMCRP-MEAF-PA21-01-EU