A Randomized Study Assess the Safety and Efficacy of Tacrolimus vs Prograf® in Renal Transplantation Treatment
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|ClinicalTrials.gov Identifier: NCT01244659|
Recruitment Status : Suspended (Study suspended by decision strategically.)
First Posted : November 19, 2010
Last Update Posted : March 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplant||Drug: Tacrolimus from EMS Drug: Prograf||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Randomized Non-inferiority Study to Compare Safety and Efficacy of Immunosuppressive Regiments Using Tacrolimus From EMS and Prograf® in Post Renal Transplanted Patients|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||December 2014|
Experimental: Tacrolimus from EMS
Group 1: Tacrolimus from EMS + Myfortic® + Steroids
Drug: Tacrolimus from EMS
Tacrolimus initial dose of 0.2 mg/kg/day Myfortic®: 720 to 1440 mg/day Steroids: methylprednisolone: first dose 500mg, 250 mg at first day and 125mg at second day, reducing to 30mg after third day post transplantation.
Active Comparator: Prograf
Group 2: Prograf® + Myfortic® + Steroids
Prograf initial dose of 0.2 mg/kg/day Myfortic®: 720 to 1440 mg/day Steroids: methylprednisolone: first dose 500mg, 250 mg at first day and 125mg at second day, reducing to 30mg after third day post transplantation.
- Efficacy [ Time Frame: day 1 to day 180 ]Incidence of biopsy confirmed acute rejection
- Safety [ Time Frame: day 1 to day 180 ]
- Patient and graft survival
- Renal function control by Estimated Glomerular Filtration Rate
- Safety, including incidence of post-transplant infection, malignances, diabetes mellitus, hepatotoxicity, blood pressure control and lipidic profile evaluation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244659
|Santa Casa de Misericórdia de Porto Alegre|
|Porto Alegre, RS, Brazil, 90020090|
|Study Director:||Felipe Pinho, MD||EMS|