A long-term clinical study to evaluate the safe and effective use of the investigational drug sotrastaurin in patients with a donor kidney graft.

• 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: 14.1Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-20
• Last Update Posted: 28 August 2012

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 166
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

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 60 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 (tBPAR) > IA, graft loss, death, or lost to follow up, up to 36 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 over 36 months of the composite endpoint of tBPAR = 1A, graft loss, death, or lost to follow-up in the two study arms.