MedTrace Logo

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 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1400

Last updated 2019-10-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Vifor Fresenius Medical Care Renal Pharma

    lead INDUSTRY

Principal Investigators

  • Sebastian Walpen, Dr. · Vifor Fresenius Medical Care Renal Pharma

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-06
Primary Completion
2019-04-06
Completion
2019-04-06

Countries

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

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02687594 on ClinicalTrials.gov