A 24 month extension to a 12-month open label, randomized, multicenter study evaluating efficacy, safety and tolerability of oral AEB071 plus tacrolimus (converted to myfortic after 3 months), vs. myfortic plus tacrolimus in de novo renal transplant recipients - ND

Active, not recruiting

• Conditions: de novo renal transplant; MedDRA version: 9.1Level: LLTClassification code 10038533Term: Renal transplant

• Registration Number: EUCTR2007-002986-11-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

The patient has given written informed consent to participate in the extension study. The patient has been maintained on AEB071/myfortic or tacrolimus/myfortic, consistent with their original randomization, 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).
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

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