A 12 to 42-month extension to a 12-month, open-label, randomised, multicenter, sequential cohort, dose finding study to evaluate the efficacy, safety and tolerability of oral AEB071 versus Neoral in combination with Certican, Simulect and corticosteroids in de novo adult renal transplant recipients - A2206E1

• Conditions: To provide continued treatment and to assess the long term safety, efficacy and tolerability of oral AEB071 plus Certican vs. Neoral plus Certican in de novo renal transplant recipients.; MedDRA version: 14.0Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2008-000531-18-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-01
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria:

The patient has given written informed consent to participate in the extension study.

The patient has been maintained on AEB071/Certican® or Neoral®/Certican®, consistent with their original randomisation, at their core study Month 12 visit.

Women capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s), as per [core study protocol].
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Inability or unwillingness to comply with the immunosuppressive regimen or the protocol.

Pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Characterise the general and renal-specific glomerular filtration rate (GFR) (MDRD) safety profile, up to 48 months post-transplantation, of renal transplant patients treated with AEB071 in combination with Certican (CNI free) versus a standard CNI-based regimen.;Secondary Objective: Characterise the efficacy profile, composite endpoint of biopsy proven acute rejection (BPAR) > IA, graft loss, death, or lost to follow up, up to 48 months post-transplantation, of renal transplant patients treated with AEB071 in combination with Certican (CNI free) versus a standard CNI based regimen.<br><br>;Primary end point(s): The key efficacy parameter is the incidence of the composite endpoint of BPAR = 1A, graft loss, death, or lost to follow-up.