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NCT00782821 · ClinicalTrials.gov registry record · Phase 4
Randomized Trial of Induction Therapies in High Immunological Risk Kidney Transplant Recipients
A Phase 4 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT00782821: Completed Phase 4 study, sponsored by University of Cincinnati.
NCT00782821 is a Phase 4 study that has completed, run by University of Cincinnati. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00782821, a Phase 4 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this research study is to find out the effects of adding B lymphocyte modulating agents in patients at risk for rejection receiving an anti-rejection (immunosuppressive) regimen of Thymoglobulin® induction with Prograf®, Cellcept® and corticosteroid therapy.
Primary Outcome
Antibody mediated rejection demonstrated to be due to, atleast in part, to anti-donor antibody at 6 months by Banff 97' criteria. Acute rejection IA - cases with significant interstitial infiltration (\>25% of parenchyma affected) and foci of moderate tubulitis (\>4 mononuclear cells/tubular cross section or group of 10 tubular cells). IB - cases with significant interstitial infiltration (\>25% of parenchyma affected) and foci of severe tubulitis (\>10 mononuclear cells/tubular cross section
Interventions
- DRUG Velcade
- DRUG Rituxan
- DRUG Rabbit Antithymocyte Globulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2008-09 |
| Est. Completion | 2013-03 |
| Phase | Phase 4 |
What the finished NCT00782821 record still lists
NCT00782821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Velcade is the first listed.
NCT00782821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00782821 about?
NCT00782821 is a clinical study titled "Randomized Trial of Induction Therapies in High Immunological Risk Kidney Transplant Recipients". The purpose of this research study is to find out the effects of adding B lymphocyte modulating agents in patients at risk for rejection receiving an anti-rejection (immunosuppressive) regimen of Thymoglobulin® induction with Prograf®, Cellcept® and corticosteroid therapy.
What is the current status of trial NCT00782821?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2008-09. Estimated completion is 2013-03.
What interventions are being tested in trial NCT00782821?
The interventions under investigation include: Velcade (DRUG), Rituxan (DRUG), Rabbit Antithymocyte Globulin (DRUG).
Who is sponsoring clinical trial NCT00782821?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00782821's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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