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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00307125
The ClinicalTrials.gov registry entry for NCT00307125 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 757 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rituximab plus immunosuppression is the first listed.
NCT00307125 reports 0 study locations.
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.
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