Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03737214 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Long-term Safety and Tolerability of Lucerastat in Adult Subjects With Fabry Disease
A Phase 3 study of Fabry Disease, sponsored by Idorsia Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 107
- Enrollment target
- 20
- Study locations
NCT03737214: Active Phase 3 study of Fabry Disease, sponsored by Idorsia Pharmaceuticals.
NCT03737214 is a Phase 3 study of Fabry Disease that is active but no longer recruiting, run by Idorsia Pharmaceuticals. The registered enrollment target is 107 participants, below the 539-participant average among 32 other Fabry Disease trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03737214, a Phase 3 study of Fabry Disease, is active but no longer recruiting, sponsored by Idorsia Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 107 participants
- Enrollment target
- 20
- Study locations
Study Summary
A study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease. This study includes a sub-study evaluating kidney Gb3 inclusions (and other histologic lesions) in male participants with classic Fabry disease who have been treated for at least 2 years with lucerastat monotherapy in study ID-069A302.
Conditions Studied
Interventions
- DRUG Lucerastat
Study Locations (20)
Other
- Royal Melbourne Hospital - Department of Nephrology - Parkville
- Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie und Dialyse - Vienna
- University Hospital Ghent (UZ Ghent) - Ghent
- University Hospital Gasthuisberg, Leuven (UZ Leuven) - Leuven
- University of Calgary - Heritage Medical Research Clinic - Calgary
California
- University of California Irvine - Irvine
- UCSF Benioff Children's Hospital Oakland - Oakland
Texas
- Renal Disease Research Institute LLC - Dallas
- Baylore University Medical Center - Dallas
Alabama
- University of Alabama at Birmingham - Nephrology Research Clinic - Birmingham
Florida
- University of Florida Clinical and Translational Science Institute, UF Clinical Research Center - Gainesville
Illinois
- Rush University Medical Center - Dept of Pediatrics - Chicago
Iowa
- University of Iowa Stead Family Children's Hospital - Division of Medical Genetics - Iowa City
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2018-12-18 |
| Est. Completion | 2029-11 |
| Phase | Phase 3 |
What the registry record for NCT03737214 still lists
NCT03737214 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 539-participant average among 32 other Fabry Disease trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Fabry Disease appearing as the primary indexed condition, and to 1 intervention - of which Lucerastat is the first listed.
NCT03737214 names 20 study sites across 14 states, led by Other, California, Texas.
Frequently Asked Questions
What is clinical trial NCT03737214 about?
NCT03737214 is a clinical study titled "A Study to Evaluate the Long-term Safety and Tolerability of Lucerastat in Adult Subjects With Fabry Disease". A study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease. This study includes a sub-study evaluating kidney Gb3 inclusions (and other histologic lesions) in male participants with classic Fabry disease who have been treated for at least 2 yea...
What is the current status of trial NCT03737214?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2018-12-18. Estimated completion is 2029-11.
What conditions does trial NCT03737214 study?
This clinical trial studies the following conditions: Fabry Disease.
What interventions are being tested in trial NCT03737214?
The interventions under investigation include: Lucerastat (DRUG).
Who is sponsoring clinical trial NCT03737214?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03737214 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fabry Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03737214's enrollment target sits among peer trials
107 6th of 32 higher than 27 of 32 other Fabry Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fabry Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of Migalastat in Pediatric Subjects (2 to <12 Yrs) With Fabry Disease and Amenable GLA Variants
RECRUITING · Phase 3
-
A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry Disease
ACTIVE NOT RECRUITING · Phase 3
-
Open Label Extension of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Every 4 Weeks in Adult Fabry Disease Patients
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease
ACTIVE NOT RECRUITING · Phase 3
-
Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05491668 · 107 participants
Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI
- NCT06041594 · 107 participants · NA
Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
- NCT06081426 · 107 participants · NA
Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)
- NCT06527599 · 107 participants · NA
Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI