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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-06

Study Completion Date

2019-04-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia

NCT02688764

Hyperphosphatemia

TERMINATED PHASE3

Clinical Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

NCT04767581

Hyperphosphatemia

COMPLETED PHASE3

Clinical Study of KHK7791 in Hyperphosphatemia Patients on Peritoneal Dialysis

NCT04766385

Hyperphosphatemia

COMPLETED PHASE3

Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

NCT04766398

Hyperphosphatemia

COMPLETED PHASE3

Study of Phosphate Levels in Patients With Chronic Kidney Disease

NCT00824460

Chronic Kidney Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperphosphatemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

single group

sucroferric oxyhydroxide

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PA21 (Velphoro)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No