Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients

Novartis

Status and phase

Completed

Phase 4

Conditions

Kidney Transplantation

Treatments

Drug: Everolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT00170885

CRAD001AIT02

Details and patient eligibility

About

The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion regimen.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Recipients of deceased, living unrelated, or non-human leukocyte antigen (HLA) identical living related donor renal transplant who actually have a viable kidney transplant at the time of randomization (within 24 hours of graft reperfusion)
The renal cold ischemic time must be < 36 hours.
The age of the donor must be between 15 and 65 years.

Exclusion criteria

Patients who are recipients of multiple organ transplants, including more than one kidney
Patients who have previously received an organ transplant which failed within one year
Patients with current panel reactive T-cell antibody titers of 50% or more
Patients who are recipients of A-B-O incompatible transplants or T-cell crossmatch positive transplant

Other protocol-defined exclusion criteria may apply.