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Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT00154284•Novartis

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This is a combined analysis using 81 patients randomized and treated in CRAD001A2419 (NCT00154284) with 33 randomized and treated in CRAD001A2423 (NCT00170807). This approach is reflected in the protocol amendments for each study, and the one clinical study report for both.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

July 1, 2005

Primary Completion Date

July 1, 2008

Completion Date

July 1, 2008

Last Updated

August 9, 2018

Enrollment

114

ACTUAL participants

Conditions

Organ Transplantation, Renal Transplantation

Interventions

Everolimus (Certican)

DRUG

Cyclosporine (Neoral)

DRUG

Steroid

DRUG

Basiliximab (Simulect)

DRUG