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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)

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ClinicalTrials.gov Identifier: NCT02687594
Recruitment Status : Active, not recruiting
First Posted : February 22, 2016
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Vifor Fresenius Medical Care Renal Pharma

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.


Condition or disease Intervention/treatment
Hyperphosphatemia Drug: sucroferric oxyhydroxide

Study Type : Observational
Actual Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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 Name: PA21 (Velphoro)




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687594


Locations
France
Centre Hospitalier LYON-SUD
Pierre Benite, France, 69495
Germany
Klinikum Coburg
Coburg, Germany, 96450
Greece
General Hospital of Athens Laiko
Athens, Greece
Italy
Ospedale Maggiore Policlinico
Milano, Italy
Netherlands
VU University Medical Center
Amsterdam, Netherlands, 1007 MB
Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
United Kingdom
Salford Royal Hospitals NHS Trust
Manchester, United Kingdom
Sponsors and Collaborators
Vifor Fresenius Medical Care Renal Pharma
Investigators
Study Chair: Sebastian Walpen, Dr. Vifor Fresenius Medical Care Renal Pharma

Responsible Party: Vifor Fresenius Medical Care Renal Pharma
ClinicalTrials.gov Identifier: NCT02687594     History of Changes
Other Study ID Numbers: VFMCRP-MEAF-PA21-01-EU
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics