A Randomized Study Assess the Safety and Efficacy of Tacrolimus vs Prograf® in Renal Transplantation Treatment
- Registration Number
- NCT01244659
- Lead Sponsor
- EMS
- Brief Summary
Comparison of safety and efficacy of immunosuppressive regiments using tacrolimus from EMS and Prograf® in post renal transplanted patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Age > 18 year old
- Patient is receiving kidney from live or death donor
- Kidney donor younger than 65 years old
- PRA ≤ 30%
- Negative pregnancy test for women
- Patient agreement to practice birth control
- Patient has been fully informed and has given written informed consent
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Exclusion Criteria
- HLA identical
- Patient multi-organ transplant recipient
- Any pathology or past medical condition that can interfere with this protocol
- Allergy or intolerance of any study medication
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tacrolimus from EMS Tacrolimus from EMS Group 1: Tacrolimus from EMS + Myfortic® + Steroids Prograf Prograf Group 2: Prograf® + Myfortic® + Steroids
- Primary Outcome Measures
Name Time Method Efficacy day 1 to day 180 Incidence of biopsy confirmed acute rejection
- Secondary Outcome Measures
Name Time Method Safety day 1 to day 180 1. Patient and graft survival
2. Renal function control by Estimated Glomerular Filtration Rate
3. Safety, including incidence of post-transplant infection, malignances, diabetes mellitus, hepatotoxicity, blood pressure control and lipidic profile evaluation.
Trial Locations
- Locations (1)
Santa Casa de Misericórdia de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil