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NCT01399593 · ClinicalTrials.gov registry record · Phase 2
Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
A Phase 2 study, sponsored by Alexion Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT01399593: Clinical Trial Phase 2 study, sponsored by Alexion Pharmaceuticals.
NCT01399593 is a Phase 2 study that was terminated before completion, run by Alexion Pharmaceuticals. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01399593, a Phase 2 study, was terminated before completion, sponsored by Alexion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study Summary
The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization therapy.
Primary Outcome
The primary efficacy variable was a binary outcome variable where patients meeting the composite endpoint of the occurrence of 1) biopsy-proven acute AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up definition at Week 9 post-transplantation were considered treatment failures and all others were considered treatment successes.
Interventions
- DRUG Eculizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2011-11-02 |
| Est. Completion | 2015-11-13 |
| Phase | Phase 2 |
Why NCT01399593 stopped before completion
NCT01399593 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 1 intervention - of which Eculizumab is the first listed.
NCT01399593 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01399593 about?
NCT01399593 is a clinical study titled "Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization". The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization therapy.
What is the current status of trial NCT01399593?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2011-11-02. Estimated completion is 2015-11-13.
What interventions are being tested in trial NCT01399593?
The interventions under investigation include: Eculizumab (DRUG).
Who is sponsoring clinical trial NCT01399593?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01399593's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 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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