A Randomized Study Assess the Safety and Efficacy of Tacrolimus vs Prograf® in Renal Transplantation Treatment
NCT ID: NCT01244659
Last Updated: 2021-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2014-05-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tacrolimus from EMS
Group 1: Tacrolimus from EMS + Myfortic® + Steroids
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
Group 2: Prograf® + Myfortic® + Steroids
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient multi-organ transplant recipient
* Any pathology or past medical condition that can interfere with this protocol
* Allergy or intolerance of any study medication
18 Years
ALL
No
Sponsors
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EMS
INDUSTRY
Responsible Party
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Principal Investigators
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Felipe Pinho, MD
Role: STUDY_DIRECTOR
EMS
Locations
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Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Other Identifiers
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TACEMS0410
Identifier Type: -
Identifier Source: org_study_id
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