Everolimus in a Cyclosporine Microemulsion-Free Regimen Compared to a Low-Dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients

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 transplant recipients.

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

Secondary outcome:

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. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

than kidney.

- Recipients of non-heart beating donor organs.

Other protocol-defined exclusion criteria may apply.

Last updated: January 15, 2008