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NCT01755858 · ClinicalTrials.gov registry record · Phase 1
Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery
A Phase 1 study, sponsored by Stealth BioTherapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01755858: Clinical Trial Phase 1 study, sponsored by Stealth BioTherapeutics.
NCT01755858 is a Phase 1 study that was terminated before completion, run by Stealth BioTherapeutics. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01755858, a Phase 1 study, was terminated before completion, sponsored by Stealth BioTherapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This was a Phase 2a prospective, single center, randomized, double-blind, placebo-controlled study designed to assess the efficacy, pharmacokinetics, safety and tolerability of IV elamipretide for reduction of reperfusion injury in subjects with Atherosclerotic Renal Artery Stenosis (ARAS), who are undergoing percutaneous transluminal angioplasty of the renal artery (PTRA).
Primary Outcome
Change in mean glomerular filtration rate (GFR), as measured by iothalamate clearance, from baseline (pre-percutaneous renal artery angioplasty, or pre-PTRA) and 8 weeks post-PTRA..
Interventions
- DRUG Placebo
- DRUG Bendavia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-12 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
Why NCT01755858 stopped before completion
NCT01755858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 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.
NCT01755858 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01755858 about?
NCT01755858 is a clinical study titled "Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery". This was a Phase 2a prospective, single center, randomized, double-blind, placebo-controlled study designed to assess the efficacy, pharmacokinetics, safety and tolerability of IV elamipretide for reduction of reperfusion injury in subjects with Atherosclerotic Renal Artery Stenosis (ARAS), who are ...
What is the current status of trial NCT01755858?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2012-12. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01755858?
The interventions under investigation include: Placebo (DRUG), Bendavia (DRUG).
Who is sponsoring clinical trial NCT01755858?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01755858's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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