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NCT01839526 · ClinicalTrials.gov registry record · Phase 1
A Study of Renal Function in Treatment-naïve, Young Male Patients With Fabry Disease
A Phase 1 study, sponsored by Genzyme, a Sanofi Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT01839526: Clinical Trial Phase 1 study, sponsored by Genzyme, a Sanofi Company.
NCT01839526 is a Phase 1 study that was terminated before completion, run by Genzyme, a Sanofi Company. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01839526, a Phase 1 study, was terminated before completion, sponsored by Genzyme, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
No investigational drug will be administered in this study for the treatment of Fabry disease. This will be a multicenter, multinational, non-treatment, cross-sectional study of young male patients with Fabry disease who have not yet initiated interventional treatment for this disease. The study will consist of a screening visit(s), a clinical investigation visit(s), and a follow-up phone contact. The objectives of the study are: * To document renal function and other Fabry disease manifestations across age in treatment-naïve, young male patients with Fabry disease. * To provide a reference group for comparison with interventional clinical trials of Fabry disease. The duration of each patient's participation in the study, inclusive of the screening visit and follow-up phone contact, will be approximately 12 weeks.
Primary Outcome
Tests are performed only for patients who are not on chronic dialysis and/or have not received a kidney transplant.
Interventions
- DRUG Iohexol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2013-05 |
| Est. Completion | 2016-09 |
| Phase | Phase 1 |
Why NCT01839526 stopped before completion
NCT01839526 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which Iohexol is the first listed.
NCT01839526 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01839526 about?
NCT01839526 is a clinical study titled "A Study of Renal Function in Treatment-naïve, Young Male Patients With Fabry Disease". No investigational drug will be administered in this study for the treatment of Fabry disease. This will be a multicenter, multinational, non-treatment, cross-sectional study of young male patients with Fabry disease who have not yet initiated interventional treatment for this disease. The study wi...
What is the current status of trial NCT01839526?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2013-05. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01839526?
The interventions under investigation include: Iohexol (DRUG).
Who is sponsoring clinical trial NCT01839526?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01839526's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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