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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00078559
The ClinicalTrials.gov registry entry for NCT00078559 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 268-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (96% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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