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NCT01665391 · ClinicalTrials.gov registry record · Phase 2
A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)
A Phase 2 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT01665391: Completed Phase 2 study, sponsored by Genzyme, a Sanofi Company.
NCT01665391 is a Phase 2 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01665391, a Phase 2 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
The primary objectives of this trial are as follows: * to compare the achievement of a partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumab versus placebo * to compare the safety profile of patients treated with fresolimumab versus placebo The secondary objectives are as follows: * To compare the reduction in proteinuria in patients treated with fresolimumab versus placebo * To evaluate fresolimumab dose-dependent reduction in proteinuria * To compare the change in renal function (estimated glomerular filtration rate \[eGFR\]) in patients treated with fresolimumab versus placebo * To evaluate the multiple-dose pharmacokinetics of fresolimumab
Interventions
- DRUG Placebo
- DRUG fresolimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
What the finished NCT01665391 record still lists
NCT01665391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01665391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01665391 about?
NCT01665391 is a clinical study titled "A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)". The primary objectives of this trial are as follows: * to compare the achievement of a partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumab versus placebo * to compare the safety profile of patients treated with fr...
What is the current status of trial NCT01665391?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2012-08. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01665391?
The interventions under investigation include: Placebo (DRUG), fresolimumab (DRUG).
Who is sponsoring clinical trial NCT01665391?
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 NCT01665391's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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