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Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01244659

Enrollment

Registered

2010-11-19

Start date

2014-05-31

Completion date

2014-12-31

Last updated

2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplant

Keywords

Tacrolimus, Immunosuppressive Agents, Kidney transplantation

Brief summary

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

Interventions

DRUGTacrolimus 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.

DRUGPrograf

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy	day 1 to day 180	Incidence of biopsy confirmed acute rejection

Secondary

Measure	Time frame	Description
Safety	day 1 to day 180	1. Patient and graft survival 2. Renal function control by Estimated Glomerular Filtration Rate 3. Safety, including incidence of post-transplant infection, malignances, diabetes mellitus, hepatotoxicity, blood pressure control and lipidic profile evaluation.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026