A 24-month Extension to a one-year, multicentre, double-blinded, double-dummy, randomized study to evaluate the safety and efficacy of two doses of FTY720 combined with full-dose Neoral and steroids versus Cellcept combined with full-dose Neoral and steroids, in de novo adult renal transplant recipients.
- Conditions
- Prophylaxis of kidney allograft rejection in de novo adult renal transplant recipientsMedDRA version: 7.0Level: LLTClassification code 10023439
- Registration Number
- EUCTR2004-000587-26-HU
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 690
a)The patient has given written informed consent to participate in the extension study.
b)The patient has completed the core study (through 12 months post-transplantation, either being maintained on study medication or having attended the Follow-up visits up to Month 12 after being discontinued from 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 medication.
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
Patients with any medical or psychosocial condition which the investigator believes would hinder compliance with the study requirements.
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