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NCT Number: 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)

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.

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Key information

Conditions

Hyperphosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier LYON-SUD, Pierre-Bénite, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PA21 (Velphoro)

Primary outcomes

  1. Incidence of Adverse Drug Reactions (ADRs)

    Time frame: through study completion, up to 42 months

  2. Proportion of Adverse Drug Reactions (ADRs)

    Time frame: through study completion, up to 42 months

Secondary outcomes

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

    Time frame: through study completion, up to 42 months

    Patient reported outcomes will be evaluated by descriptive statistics

  2. Patient Reported Outcome questionnaire - Perceived Pill based on the ACTG questionnaire

    Time frame: through study completion, up to 42 months

    Patient reported outcomes will be evaluated by descriptive statistics

  3. Patient Reported Outcome questionnaire - Treatment satisfaction based on the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9)

    Time frame: through study completion, up to 42 months

    Patient reported outcomes will be evaluated by descriptive statistics

Sponsors and collaborators

Lead sponsor

Vifor Fresenius Medical Care Renal Pharma

Industry

Registry information

Official study 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

Acronym: VERIFIE

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 22, 2016
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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