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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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (195% higher). 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 |
What the finished NCT00170053 record still lists
NCT00170053 is an interventional study that assigns participants to a tested intervention. The registered 177 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (195% higher).
The record links to 0 conditions, and to 1 intervention - of which Sirolimus is the first listed.
NCT00170053 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00170053's enrollment target sits among peer trials
177 313th of 2000 higher than 1,685 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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