A two-year extension to a one-year, multicenter, partially blinded, double-dummy, randomized study to evaluate the efficacy and safety of FTY720 combined with reduced-dose or full-dose Neoral and corticosteroids versus mycophenolate mofetil (MMF, CellCept) combined with full-dose Neoral and corticosteroids, 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
- EUCTR2004-004958-63-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 718
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) and has been maintained on study medication (FTY720/Neoral or MMF/Neoral in combination with corticosteroids), consistent with their original randomization, at their Month 12 visit.
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
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 Main Objective: The purpose of this two-year extension is to allow patients who have completed the one-year core study to continue treatment with FTY720 or MMF in combination with reduced or full-dose Neoral (per randomized treatment assignment) beyond the first year post-transplantation for a total of three years follow-up. ;Secondary Objective: The two-year extension will provide long term efficacy and safety data on all patients enrolled into the core study.;Primary end point(s): Biopsy proven acute rejection, graft loss, death and discontinuation from the study.
- Secondary Outcome Measures
Name Time Method