a randomized, open-label study to evaluate the safety and efficacy of delayed introduction of sirolimus and concomitant tacrolimus elimination in de novo renal allograft recipients - early transition from tacrolimus to sirolimus
- Conditions
- noMedDRA version: 9.1Level: SOCClassification code 10038359
- Registration Number
- EUCTR2009-016762-87-IT
- Lead Sponsor
- OSPEDALE MAGGIORE DI MILANO (IRCCS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
low immunological risk recipients of a de novo renal transplant
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
Exclusion Criteria
pregancy status, early acute rejection, infections, neoplasia,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate the equivalent efficacy of the experimental protocol as compared to the traditional immunesuppressive regimen on graft survival at the 1st year;Secondary Objective: to evaluate the difference in safety profile;Primary end point(s): graft survival
- Secondary Outcome Measures
Name Time Method