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-AT

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

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 treated 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.

Secondary Outcome Measures