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.)
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01244659
First received: November 18, 2010
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Renal Transplant
Drug: Tacrolimus from EMS
Drug: Prograf
Phase 3

Study Type: Interventional
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:


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 ]
    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.


Estimated Enrollment: 60
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)
Arms Assigned Interventions
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244659

Locations
Brazil
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, RS, Brazil, 90020090
Sponsors and Collaborators
EMS
Investigators
Study Director: Felipe Pinho, MD EMS
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01244659     History of Changes
Other Study ID Numbers: TACEMS0410
Study First Received: November 18, 2010
Last Updated: March 1, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by EMS:
Tacrolimus
Immunosuppressive Agents
Kidney transplantation

Additional relevant MeSH terms:
Immunosuppressive Agents
Tacrolimus
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014