A RANDOMIZED, OPEN-LABEL, COMPARATIVE EVALUATION OF THE SAFETY AND EFFICACY OF SIROLIMUS VERSUS CYCLOSPORINE WHEN COMBINED IN A REGIMEN CONTAINING BASILIXIMAB, MYCOPHENOLATE MOFETIL, AND CORTICOSTEROIDS IN PRIMARY DE NOVO RENAL ALLOGRAFT RECIPIENTS
- Conditions
- The rationale for the present study is to assess whether a CNI-free regimen including antibody induction, sirolimus and mycophenolate mofetil MMF results in improved long-term renal function without having a negative impact on safety or immunosuppressive efficacy, and to further examine the potential of sirolimus to reduce the severity and/or progression of Chronic allograft nephropaty CAN , wich could represent a major advance in the field of transplantation.MedDRA version: 6.1Level: PTClassification code 10023439
- Registration Number
- EUCTR2004-000973-69-IT
- Lead Sponsor
- WYETH LEDERLE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
Are the trial subjects under 18? yes
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
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method