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Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
NCT00113269 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00113269
The ClinicalTrials.gov registry entry for NCT00113269 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 501 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00113269 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, New York, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00113269?
This trial is sponsored by Astellas Pharma, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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