Not Signed In -
Tacrolimus |
FK 506; Prograf |
Clinical Trial: Safety/Efficacy of Induction Agents with Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
This study is currently recruiting patients.
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Kidney Transplantation | Drug: alemtuzumab Drug: basiliximab Drug: rabbit anti-thymocyte globulin | Phase IV |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Phase 4, Randomized, Open-label, Comparative, Multicenter Study to Assess the Safety and Efficacy of Induction Agents, Alemtuzumab, Basiliximab or Rabbit Anti-thymocyte Globulin in Combination with Tacrolimus, MMF, and a Rapid Steroid Withdrawal in Renal Transplant Recipients
Further Study Details:
Primary Outcomes: The incidence of biopsy-confirmed acute rejection at 6 and 12 months
Secondary Outcomes: Time to first acute rejection episode; One year patient and graft survival rates
Expected Total Enrollment: 360
Secondary Outcomes: Time to first acute rejection episode; One year patient and graft survival rates
Expected Total Enrollment: 360
Study start: May 2005
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, MMF and a rapid steroid withdrawal.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Recipient of a primary or re-transplanted deceased donor kidney or a primary or re-transplanted non-HLA living donor kidney (ie., HLA identical or 0 antigen mismatch deceased donor kidneys are allowed).
Exclusion Criteria:
- Patient has previously received an organ transplant other than a kidney
- Patient receiving chronic steroid therapy at time of transplant
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00113269
Medical Information 1-800-727-7003 clintrials.info@us.astellas.com
California
Investigational Site, San Francisco, California, 94115, United States; Recruiting
Investigational Site, San Diego, California, 92123, United States; Recruiting
Ohio
Investigational Site, Cincinnati, Ohio, 45267, United States; Recruiting
More Information
Study ID Numbers: 20-04-003
Record last reviewed: June 2005
Last Updated: June 30, 2005
Record first received: June 7, 2005
ClinicalTrials.gov Identifier: NCT00113269
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-05
Record last reviewed: June 2005
Last Updated: June 30, 2005
Record first received: June 7, 2005
ClinicalTrials.gov Identifier: NCT00113269
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-05
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