NCT01244659

A Randomized Study Assess the Safety and Efficacy of Tacrolimus vs Prograf® in Renal Transplantation Treatment

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: EMS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Comparison of safety and efficacy of immunosuppressive regiments using tacrolimus from EMS and Prograf® in post renal transplanted patients.

Conditions

• Renal Transplant

Interventions

Type	Name	Description
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.
DRUG	Prograf	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.

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-08-01
• Completion: 2014-12-01
• First posted: 2010-11-19
• Last updated: 2021-02-24

Locations

1 site across 1 country: Brazil