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NCT02795676 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function
A Phase 3 study of Fabry Disease, sponsored by Protalix.
- Completed
- Registry status
- Phase 3
- Development phase
- 78
- Enrollment target
- 20
- Study locations
NCT02795676: Completed Phase 3 study of Fabry Disease, sponsored by Protalix.
NCT02795676 is a Phase 3 study of Fabry Disease that has completed, run by Protalix. The registered enrollment target is 78 participants, below the 540-participant average among 32 other Fabry Disease trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02795676, a Phase 3 study of Fabry Disease, has completed, sponsored by Protalix.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 78 participants
- Enrollment target
- 20
- Study locations
Study Summary
This was a randomized, double-blind, active control study of the enzyme replacement therapy (ERT) drug PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal function. Patients who had been treated for approximately 1 year with agalsidase beta and who had been on a stable dose of that product for at least 6 months were randomized in a 2:1 ratio to either switch to PRX-102 or to continue treatment with agalsidase beta. Both treatments were delivered by intravenous infusions every two weeks, at a dosage of 1 mg/kg.
Primary Outcome
The individual annualized mean change (slope) in eGFR (mL/min/1.73 m\^2/year) is an estimate of the individual patient's annualized change in eGFR, which is derived from the eGFR assessments over time, for up to 24 months. The individual annualized mean change (slope) in eGFR is estimated for each patient with at least 4 eGFR observations. For patients with fewer than 4 eGFR observations, the slope will be missing.
Conditions Studied
Interventions
- BIOLOGICAL PRX-102 (pegunigalsidase alfa)
- BIOLOGICAL agalsidase beta
Study Locations (20)
Other
- Turku University Central Hospital - Turku
- Hôpital Raymond Poincaré - Paris
- Semmelweis Egyetem - Budapest
- Azienda Ospedaliera Universitaria "Federico II" - Naples
California
- University of California Irvine Center - Orange
- University of California San Diego - San Diego
Texas
- Institute of Metabolic Disease, Baylor Healthcare - Dallas
- Renal Disease Research Institute, LLC - Dallas - Dallas
Alabama
- UAB Medicine - Birmingham
Arizona
- Phoenix Children's Hospital - Phoenix
Georgia
- Emory University School of Medicine - Atlanta
Iowa
- University of Iowa Hosptials and Clinics - Iowa City
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2016-06 |
| Est. Completion | 2022-07 |
| Phase | Phase 3 |
What the finished NCT02795676 record still lists
NCT02795676 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 540-participant average among 32 other Fabry Disease trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Fabry Disease appearing as the primary indexed condition, and to 2 interventions - of which PRX-102 (pegunigalsidase alfa) is the first listed.
NCT02795676 names 20 study sites across 15 states, led by Other, California, Texas.
Frequently Asked Questions
What is clinical trial NCT02795676 about?
NCT02795676 is a clinical study titled "Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function". This was a randomized, double-blind, active control study of the enzyme replacement therapy (ERT) drug PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal function. Patients who had been treated for approximately 1 year with agalsidase beta and who had been on a stable dose ...
What is the current status of trial NCT02795676?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 78 participants. The study started on 2016-06. Estimated completion is 2022-07.
What conditions does trial NCT02795676 study?
This clinical trial studies the following conditions: Fabry Disease.
What interventions are being tested in trial NCT02795676?
The interventions under investigation include: PRX-102 (pegunigalsidase alfa) (BIOLOGICAL), agalsidase beta (BIOLOGICAL).
Who is sponsoring clinical trial NCT02795676?
This trial is sponsored by Protalix, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02795676 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02795676's enrollment target sits among peer trials
78 10th of 32 higher than 23 of 32 other Fabry Disease trials
participants (enrollment target), bucketed by value
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