Status:

COMPLETED

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

Lead Sponsor:

Novartis

Conditions:

Kidney Transplantation

Eligibility:

All Genders

18-75 years

Phase:

PHASE4

Brief Summary

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-dos...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2005

Trial Type :

INTERVENTIONAL

End Date :

July 1 2007

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00170885

Start Date

May 1 2005

End Date

July 1 2007

Last Update

November 16 2016

Active Locations (1)

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1

Novartis

Basel, Switzerland