Everolimus in a Cyclosporine Microemulsion-Free Regimen Compared to a Low-Dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Transplantation
Intervention: Everolimus (RAD001) (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Novartis
Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis
The purpose of this study is to evaluate the safety and efficacy of everolimus in combination
with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney
Official title: A 12 Month, Multicenter, Randomized, Parallel, Open-Label Study, to Evaluate Renal Function and Efficacy of Everolimus With Basiliximab and Cyclosporine Microemulsion Discontinuation at 3 Month Post-Transplant Versus Minimization, in de Novo Kidney Transplant Recipients
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Renal function measured by calculated glomerular filtration rate (GFR), serum creatinine and calculated creatinine clearance
Incidence of biopsy-proven acute rejection (BPAR) episodes, graft loss, death or loss to follow-up after 12 months
Incidence of graft loss, death, BPAR episodes, antibody treated acute rejection episodes, clinically confirmed acute rejection episodes, clinically confirmed chronic rejection episodes and biopsy-proven chronic allograft nephropathy after 12 months
Safety based on adverse event (AE) reporting
Minimum age: 18 Years.
Maximum age: 65 Years.
- Recipients of a first renal transplant from a primary cadaveric or non-HLA identical
living related donor.
- Renal cold ischemic time < 36 hours.
- Age of donor < 65 years.
- Patients who have received an investigational drug within 4 weeks of baseline period.
- Patients who are recipients of multiple organ transplants, including any organ other
- Recipients of non-heart beating donor organs.
Other protocol-defined exclusion criteria may apply.
Locations and Contacts
Last updated: January 15, 2008