NCT01244659

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
3.4 years until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

November 18, 2010

Last Update Submit

February 23, 2021

Conditions

Renal Transplant

Keywords

TacrolimusImmunosuppressive AgentsKidney transplantation

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    Incidence of biopsy confirmed acute rejection

    day 1 to day 180

Secondary Outcomes (1)

  • Safety

    day 1 to day 180

Study Arms (2)

Tacrolimus from EMS

EXPERIMENTAL

Group 1: Tacrolimus from EMS + Myfortic® + Steroids

Drug: Tacrolimus from EMS

Prograf

ACTIVE COMPARATOR

Group 2: Prograf® + Myfortic® + Steroids

Drug: Prograf

Interventions

Tacrolimus from EMSDRUG

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.

Tacrolimus from EMS
PrografDRUG

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.

Prograf

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020090, Brazil

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Felipe Pinho, MD

    EMS

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 19, 2010

Study Start

May 1, 2014

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

BR(1)