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

Sponsor
EMS (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01244659
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
7
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
May 1, 2014
Anticipated Primary Completion Date :
Aug 1, 2014
Anticipated Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Efficacy [day 1 to day 180]

    Incidence of biopsy confirmed acute rejection

Secondary Outcome Measures

  1. Safety [day 1 to day 180]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Santa Casa de Misericórdia de Porto Alegre Porto Alegre RS Brazil 90020090

Sponsors and Collaborators

  • EMS

Investigators

  • Study Director: Felipe Pinho, MD, EMS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EMS
ClinicalTrials.gov Identifier:
NCT01244659
Other Study ID Numbers:
  • TACEMS0410
First Posted:
Nov 19, 2010
Last Update Posted:
Feb 24, 2021
Last Verified:
Feb 1, 2021
Keywords provided by EMS
Tacrolimus
Immunosuppressive Agents
Kidney transplantation
Additional relevant MeSH terms:
Tacrolimus

Study Results

No Results Posted as of Feb 24, 2021