A two-year extension to a one-year, multicenter, open-label, randomized study to evaluate the safety and efficacy of FTY720 combined with tacrolimus and steroids versus MMF (Cellcept) combined with tacrolimus and steroids, in de novo adult renal transplant recipients.
- Conditions
- De novo kidney transplantation
- Registration Number
- EUCTR2005-000350-69-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
a)The patient has given written informed consent to participate in the extension study.
b)The patient has completed the Month 12 visit of the core study either on or off study medication.
c)Females 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) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not applicable.
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