Status:
WITHDRAWN
A Randomized Study Assess the Safety and Efficacy of Tacrolimus vs Prograf® in Renal Transplantation Treatment
Lead Sponsor:
EMS
Conditions:
Renal Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Comparison of safety and efficacy of immunosuppressive regiments using tacrolimus from EMS and Prograf® in post renal transplanted patients.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01244659
Start Date
May 1 2014
End Date
December 1 2014
Last Update
February 24 2021
Active Locations (1)
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1
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90020090