A 24-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 - ND
- Conditions
- Renal transplantMedDRA version: 9.1Level: LLTClassification code 10038533Term: Renal transplant
- Registration Number
- EUCTR2008-000531-18-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 170
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)
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
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
- Secondary Outcome Measures
Name Time Method