Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen
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A Single Arm, Prospective, Open-label, Pilot Study to Assess Effects of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen
Study Start Date
Actual Primary Completion Date
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
First or second renal transplantation (1 to 10 years post-transplant)
Treatment with sirolimus + mycophenolate mofetil + steroids + ACE inhibitor or angiotensin II receptor antagonist + statin
Treatment with a CNI or azathioprine
Vascular rejection or biopsy-proven acute rejection within 3 months prior to screening
Severe dyslipidemia Other protocol-defined inclusion / exclusion criteria may apply