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NCT00579592 · ClinicalTrials.gov registry record · NA
Campath, Rituximab, and Myfortic With Short-Course Calcineurin Inhibitor Therapy in Renal Transplanation
A NA study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT00579592 is a NA study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 11 participants.
The verdict
NCT00579592, a NA study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
The hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will obviate the need for long-term calcineurin inhibitors in renal transplantation. Most successful strategies to date have relied on the use of either tacrolimus or cyclosporine for an indefinite period of time. However, the advantage of a long term, calcineurin inhibitor free regimen may include improved renal allograft function, a lower incidence of hypertension, diabetes, and less drug related side effects. This is a non-randomized open-label pilot trial in 30 adult renal transplant patients. Subjects will receive 2 doses of Campath-1H (30mg given on Day 0 and Day 1) and a single dose of Rituximab (375mg/m2) on Day 0, given intra-operative. Subjects will take maintenance doses of prednisone and enteric coated mycophenolate sodium (Myfortic™). Subject will also be given cyclosporine (Neoral®) therapy for approximately 2 weeks (10-20 days).
Interventions
- DRUG Campath-1H, rituximab, myfortic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2006-04 |
| Est. Completion | 2007-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00579592
The ClinicalTrials.gov registry entry for NCT00579592 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Campath-1H, rituximab, myfortic is the first listed.
NCT00579592 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00579592 about?
NCT00579592 is a clinical study titled "Campath, Rituximab, and Myfortic With Short-Course Calcineurin Inhibitor Therapy in Renal Transplanation". The hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will obviate the need for long-term calcineurin inhibitors in renal transplantation. Most successful strategies to date have relied on the use of either tacrolimus or cyclosporine for an indefinite period of time. ...
What is the current status of trial NCT00579592?
This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2006-04. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00579592?
The interventions under investigation include: Campath-1H, rituximab, myfortic (DRUG).
Who is sponsoring clinical trial NCT00579592?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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