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Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function
NCT02795676 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02795676
The ClinicalTrials.gov registry entry for NCT02795676 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Protalix, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02795676 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02795676?
The interventions under investigation include: PRX-102 (pegunigalsidase alfa) (BIOLOGICAL), agalsidase beta (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02795676?
This trial is sponsored by Protalix, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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