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Sponsored by: |
Wyeth |
Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00428064 |
To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune, Neoral) and sirolimus versus induction with CsA and sirolimus followed by CsA elimination and concentration-controlled sirolimus.
Condition | Intervention | Phase |
Renal Transplantation |
Drug: Sirolimus Drug: cyclosporine |
Phase III |
MedlinePlus related topics: | Kidney Transplantation |
ChemIDplus related topics: | Cyclosporine Cyclosporin Sirolimus |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label Study of Continuous Therapy With Cyclosporine and Sirolimus Versus Induction With Cyclosporine and Sirolimus Followed by Continuous Therapy With Sirolimus in Renal Allograft Recipients |
Estimated Enrollment: | 408 |
Study Start Date: | May 1998 |
Estimated Study Completion Date: | June 2004 |
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 0468H1-310 |
First Received: | January 25, 2007 |
Last Updated: | January 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00428064 |
Health Authority: | European Union: European Medicines Agency |
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