A Randomized Study Assess the Safety and Efficacy of Tacrolimus vs Prograf® in Renal Transplantation Treatment
This study has suspended participant recruitment.
(Study suspended by decision strategically.)
Information provided by (Responsible Party):
First received: November 18, 2010
Last updated: March 1, 2013
Last verified: March 2013
Comparison of safety and efficacy of immunosuppressive regiments using tacrolimus from EMS and Prograf® in post renal transplanted patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by EMS:
Primary Outcome Measures:
- Efficacy [ Time Frame: day 1 to day 180 ] [ Designated as safety issue: Yes ]Incidence of biopsy confirmed acute rejection
Secondary Outcome Measures:
- Safety [ Time Frame: day 1 to day 180 ] [ Designated as safety issue: Yes ]
- 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.
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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.
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