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NCT01244659 Clinical Trial

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

Renal Transplant Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01244659
Other study ID # TACEMS0410
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date May 2014
Est. completion date December 2014

Study information
Verified date February 2021
Source EMS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
Brazil Santa Casa de Misericórdia de Porto Alegre Porto Alegre RS

Sponsors (1)
Lead Sponsor Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy Incidence of biopsy confirmed acute rejection day 1 to day 180
Secondary Safety 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.		 day 1 to day 180
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