Concentration controlled Everolimus with reduced dose Neoral versus mycophenolate mofetil with standard dose Neoral in de novo renal transplant adult recipients treated with basiliximab and corticosteroids

Phase 3

• Conditions: de novo Kidney Transplantation

• Registration Number: JPRN-jRCT2080220571
• Lead Sponsor: ovartis Pharma K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Inclusion Criteria:
-Male or female de novo renal transplant recipients between 18 and 65 years of age
-Patients who have given written informed consent to participate in the study
-Females capable of becoming pregnant must have a negative pregnancy test prior to randomization.

Exclusion Criteria

-Recipients of dual kidney transplants
-Recipients of kidneys from HLA-identical living related donors
-Donor organ with a cold ischemia time >24 hours
-Donor age greater than 65 years
-Patients with any history of coagulopathy or medical condition requiring long-term anticoagulation which would preclude renal biopsy after transplantation. (Low dose aspirin treatment or interruption of chronic anticoagulant is allowed)

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy failure rate (treated BPAR, graft loss, death or loss to follow-up) [Time frame; 12 months]