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NCT00346151 · ClinicalTrials.gov registry record · Phase 2
Belatacept to Prevent Organ Rejection in Kidney Transplant Patients
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT00346151: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00346151 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00346151, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Belatacept is an experimental medication shown in clinical trials to have immune system suppression properties in people who have had renal (e.g., kidney) transplants. This study will determine whether a combination of anti-rejection drugs, including belatacept, can prevent the rejection of a first-time, non-human leukocyte antigen (HLA) identical renal transplant and allow patients to be safely withdrawn from anti-rejection therapy one year post-transplant.
Primary Outcome
Cumulative incidence of acute rejection\[1\] at 6 months post-transplant based on local pathology biopsy reads 1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater\[2\] 2. Reference: Racusen LC, Solez K, Colvin RB et al,
Interventions
- DRUG Sirolimus
- DRUG Belatacept
- DRUG methylprednisolone
- DRUG Anti-thymocyte globulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2006-12 |
| Est. Completion | 2010-02 |
| Phase | Phase 2 |
Why NCT00346151 stopped before completion
NCT00346151 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 4 interventions - of which Sirolimus is the first listed.
NCT00346151 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00346151 about?
NCT00346151 is a clinical study titled "Belatacept to Prevent Organ Rejection in Kidney Transplant Patients". Belatacept is an experimental medication shown in clinical trials to have immune system suppression properties in people who have had renal (e.g., kidney) transplants. This study will determine whether a combination of anti-rejection drugs, including belatacept, can prevent the rejection of a first-...
What is the current status of trial NCT00346151?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2006-12. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00346151?
The interventions under investigation include: Sirolimus (DRUG), Belatacept (DRUG), methylprednisolone (DRUG), Anti-thymocyte globulin (DRUG).
Who is sponsoring clinical trial NCT00346151?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00346151's enrollment target sits among peer trials
5 2000th of 2000 the lowest 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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