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NCT00078559 · ClinicalTrials.gov registry record · Phase 1
Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults
A Phase 1 study of Kidney Transplantation and Kidney Disease, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT00078559: Completed Phase 1 study of Kidney Transplantation and Kidney Disease, sponsored by University of Wisconsin, Madison.
NCT00078559 is a Phase 1 study of Kidney Transplantation and Kidney Disease that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 10 participants, below the 268-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00078559, a Phase 1 study of Kidney Transplantation and Kidney Disease, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Transplant rejection occurs when a patient's body does not recognize the new organ and attacks it. Patients who have kidney transplants must take drugs to prevent transplant rejection. Alemtuzumab is a man-made antibody used to treat certain blood disorders. The purpose of this study is to test the safety and effectiveness of using alemtuzumab in combination with two other drugs, sirolimus and tacrolimus, to prevent organ rejection after kidney transplantation. This study will also test whether this combination of medications will allow patients to eventually stop taking antirejection medications entirely. Study hypothesis: A new strategy of immunosuppression using alemtuzumab, tacrolimus, and sirolimus for human renal transplantation will permit a step-wise withdrawal from immunosuppressive drugs.
Primary Outcome
Number of acute rejections\[1\] in all enrolled subjects from the time of transplantation to the end of the trial (four years post-transplant) 1. Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff\[2\] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine. 2. Reference: Racusen LC, Solez K, Colvin RB et al,T
Conditions Studied
Interventions
- DRUG Sirolimus
- DRUG Alemtuzumab
- DRUG Tacrolimus
- PROCEDURE Kidney transplant
- DRUG Methylprednisolone (or equivalent)
Study Locations (1)
Wisconsin
- University of Wisconsin - Department of Medicine - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2003-11 |
| Est. Completion | 2010-02 |
| Phase | Phase 1 |
What the finished NCT00078559 record still lists
NCT00078559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 268-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Kidney Transplantation appearing as the primary indexed condition, and to 5 interventions - of which Sirolimus is the first listed.
NCT00078559 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT00078559 about?
NCT00078559 is a clinical study titled "Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults". Transplant rejection occurs when a patient's body does not recognize the new organ and attacks it. Patients who have kidney transplants must take drugs to prevent transplant rejection. Alemtuzumab is a man-made antibody used to treat certain blood disorders. The purpose of this study is to test the ...
What is the current status of trial NCT00078559?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2003-11. Estimated completion is 2010-02.
What conditions does trial NCT00078559 study?
This clinical trial studies the following conditions: Kidney Transplantation, Kidney Disease.
What interventions are being tested in trial NCT00078559?
The interventions under investigation include: Sirolimus (DRUG), Alemtuzumab (DRUG), Tacrolimus (DRUG), Kidney transplant (PROCEDURE), Methylprednisolone (or equivalent) (DRUG).
Who is sponsoring clinical trial NCT00078559?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00078559 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00078559's enrollment target sits among peer trials
10 33rd of 33 higher than 1 of 33 other Kidney Transplantation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplantation 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.
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