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NCT00113269 · ClinicalTrials.gov registry record · Phase 4
Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
A Phase 4 study of Kidney Transplantation, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 4
- Development phase
- 501
- Enrollment target
- 20
- Study locations
NCT00113269: Completed Phase 4 study of Kidney Transplantation, sponsored by Astellas Pharma.
NCT00113269 is a Phase 4 study of Kidney Transplantation that has completed, run by Astellas Pharma. The registered enrollment target is 501 participants, above the 253-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (98% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00113269, a Phase 4 study of Kidney Transplantation, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 501 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.
Primary Outcome
A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) \& Severe (3). Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a)
Conditions Studied
Interventions
- DRUG tacrolimus
- DRUG mycophenolate mofetil
- DRUG alemtuzumab
- DRUG basiliximab
- DRUG rabbit anti-thymocyte globulin
Study Locations (20)
California
- - Los Angeles
- - Palo Alto
- - San Diego
- - San Francisco
- - San Francisco
New York
- - Hawthorne
- - New York
- - New York
District of Columbia
- - Washington D.C.
- - Washington D.C.
Florida
- - Miami
- - Tampa
Illinois
- - Chicago
- - Chicago
New Jersey
- - Livingston
- - New Brunswick
North Carolina
- - Chapel Hill
- - Durham
Alabama
- - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 501 participants |
| Start Date | 2005-05 |
| Est. Completion | 2009-03 |
| Phase | Phase 4 |
What the finished NCT00113269 record still lists
NCT00113269 is an interventional study that assigns participants to a tested intervention. The registered 501 participants enrollment target is mid-sized for trials with a published cap, above the 253-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (98% higher).
The record links to 1 condition, with Kidney Transplantation appearing as the primary indexed condition, and to 5 interventions - of which tacrolimus is the first listed.
NCT00113269 names 20 study sites across 9 states, led by California, New York, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT00113269 about?
NCT00113269 is a clinical study titled "Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients". The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.
What is the current status of trial NCT00113269?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 501 participants. The study started on 2005-05. Estimated completion is 2009-03.
What conditions does trial NCT00113269 study?
This clinical trial studies the following conditions: Kidney Transplantation.
What interventions are being tested in trial NCT00113269?
The interventions under investigation include: tacrolimus (DRUG), mycophenolate mofetil (DRUG), alemtuzumab (DRUG), basiliximab (DRUG), rabbit anti-thymocyte globulin (DRUG).
Who is sponsoring clinical trial NCT00113269?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00113269 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Transplantation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00113269's enrollment target sits among peer trials
501 4th of 33 higher than 30 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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