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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014