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NCT00307125 · ClinicalTrials.gov registry record · Phase 2
Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 757
- Enrollment target
NCT00307125: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00307125 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 757 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (469% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00307125, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 757 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether treatment with rituximab (anti-CD20, Rituxan®, MabThera®) in individuals who develop new anti-HLA antibodies after renal (kidney) transplant will promote longer-term survival of the transplanted kidney.The pilot study compares the use of rituximab (Rituxan®) + site-specific standard immunosuppression to placebo + site-specific standard immunosuppression in the treatment of circulating anti-HLA antibodies in subjects who develop de novo anti-HLA antibodies between 3-36 months after transplant.
Primary Outcome
Data were analyzed for 653 participants from the screening phase of the study. This outcome looked at the number of kidney transplant recipients that developed de novo HLA antibodies (anti-HLA Ab) post-transplant. Alloantibody is defined as an antibody produced following the introduction of an alloantigen into the system of an individual lacking that particular antigen. Alloantibodies are important mediators of acute and chronic rejection.
Interventions
- DRUG Rituximab plus immunosuppression
- DRUG Placebo plus immunosuppression
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 757 participants |
| Start Date | 2006-03 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
What the finished NCT00307125 record still lists
NCT00307125 is an interventional study that assigns participants to a tested intervention. The registered 757 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (469% higher).
The record links to 0 conditions, and to 2 interventions - of which Rituximab plus immunosuppression is the first listed.
NCT00307125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00307125 about?
NCT00307125 is a clinical study titled "Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies". The purpose of this study is to determine whether treatment with rituximab (anti-CD20, Rituxan®, MabThera®) in individuals who develop new anti-HLA antibodies after renal (kidney) transplant will promote longer-term survival of the transplanted kidney.The pilot study compares the use of rituximab (R...
What is the current status of trial NCT00307125?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 757 participants. The study started on 2006-03. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00307125?
The interventions under investigation include: Rituximab plus immunosuppression (DRUG), Placebo plus immunosuppression (DRUG).
Who is sponsoring clinical trial NCT00307125?
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 NCT00307125's enrollment target sits among peer trials
757 43rd of 2000 higher than 1,958 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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