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NCT00170053 · ClinicalTrials.gov registry record · Phase 1
Comparison of Sirolimus to Tacrolimus for Long Term Therapy in Kidney Transplant With no Steroids
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 177
- Enrollment target
NCT00170053: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT00170053 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 177 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00170053, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 177 participants
- Enrollment target
Study Summary
Kidney transplant patients will be treated with Thymoglobulin (5 days), tacrolimus (Prograf), and mycophenolate mofetil (Cellcept) from the time of transplant. They will only receive steroids for 4 days and no prednisone after that. At 1 month, they will have a kidney biopsy and if it is ok, patients will be treated long term with either continued tacrolimus/mycophenolate mofetil or be switched to sirolimus (Rapamune)/mycophenolate mofetil. This will be done randomly in a manner similar to flipping a coin. The investigators are trying to determine if after the initial therapy patients can stay off steroids long term and get better kidney function if they are treated with sirolimus compared to tacrolimus. Patients will be followed for 3 years and will repeat kidney biopsies at 1 and 2 years after transplant.
Interventions
- DRUG Sirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2005-06 |
| Est. Completion | 2008-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00170053
The ClinicalTrials.gov registry entry for NCT00170053 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 177 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sirolimus is the first listed.
NCT00170053 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00170053 about?
NCT00170053 is a clinical study titled "Comparison of Sirolimus to Tacrolimus for Long Term Therapy in Kidney Transplant With no Steroids". Kidney transplant patients will be treated with Thymoglobulin (5 days), tacrolimus (Prograf), and mycophenolate mofetil (Cellcept) from the time of transplant. They will only receive steroids for 4 days and no prednisone after that. At 1 month, they will have a kidney biopsy and if it is ok, patient...
What is the current status of trial NCT00170053?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 177 participants. The study started on 2005-06. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00170053?
The interventions under investigation include: Sirolimus (DRUG).
Who is sponsoring clinical trial NCT00170053?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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