An 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

Phase 2

Completed

Conditions: orgaanafstoting na niertransplantatie
rejection
renal transplant

Registration Number: NL-OMON37034

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion 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).

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To characterise the general and renal-specific glomerular filtration rate (GFR)<br /><br>(MDRD) safety profile, up to 60 months post transplantation, of renal<br /><br>transplant patients treated with AEB071 in combination with Certican® (CNI<br /><br>free) versus a standard CNI-based regimen.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To characterise the efficacy profile, composite endpoint of BPAR > IA, graft<br /><br>loss, death, or lost to follow up, up to 48 months post transplantation, of<br /><br>renal transplant patients treated with AEB071 in combination with Certican®<br /><br>(CNI free) versus a standard CNI-based regimen.<br /><br>Collection of efficacy data. The key efficacy parameter is the incidence over<br /><br>42 months of the composite endpoint of BPAR >= 1A, graft loss, death, or lost to<br /><br>follow-up in the two study arms.</p><br>