Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys (TIGRE)

February 22, 2017 updated by: Astellas Pharma Inc

An Open, Multicentre, Randomised, Parallel Group Study to Compare in Marginal Old-for-old Renal Transplant Patients the Safety and Efficacy of Two Treatments: Sequential Mycophenolate Mofetil/Delayed Tacrolimus Plus Steroids vs Tacrolimus Plus Mycophenolate Mofetil in Patients Requiring Induction With Anti-IL2 Antibody

The purpose of this study is to explore the safety and efficacy of two different immunosuppressive regimens (sequential tacrolimus/mycophenolate mofetil [MMF] plus steroids versus tacrolimus plus MMF, following induction with daclizumab) in recipients of marginal donor kidneys.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An open, multicentre, randomized, parallel group study to compare in marginal old-for-old renal transplant patients the safety and efficacy of two treatments: sequential mycophenolate mofetil/delayed tacrolimus plus steroids vs tacrolimus plus mycophenolate mofetil, in patients requiring induction with anti-IL2 monoclonal antibody.

Elderly (≥50 years) low risk patients (PRA grade ≤50%, in the previous 6 months) receiving an allograft transplantation of marginal kidney(s) from elderly (>65 years) donors (old-for-old allocation) will be randomized to one of the following treatment arms:

Arm1: Sequential mycophenolate mofetil/tacrolimus/steroids

Arm2: Tacrolimus/mycophenolate mofetil/steroid one single dose (perioperatively)

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
      • Cagliari, Italy, 09134
      • Milano, Italy, 30100
      • Modena, Italy, 41100
      • Padova, Italy, 35128
      • Palermo, Italy, 90127
      • Roma, Italy, 00161
      • Roma, Italy, 00168
      • Roma, Italy, 00144
      • Sassari, Italy, 35128
      • Siena, Italy, 53100
      • Treviso, Italy
      • Udine, Italy
      • Vicenza, Italy, 36100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients minimum 60 years of age undergoing a cadaveric kidney transplant
  • Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation.
  • Donors older than 60 years
  • Female patients of child bearing age agree to practice effective birth control during the study.
  • Patient has been fully informed and has given written informed consent

Exclusion Criteria:

  • Patient has significant, uncontrolled, concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer
  • Patient has previously received or is receiving an organ transplant other than kidney or a kidney retransplant
  • Any pathology or medical condition that can interfere with this protocol study proposal
  • Other exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
oral
Drug: tacrolimus
immunosuppression
Other Names:
  • Prograf
  • FK506
Drug: mycophenolate mofetil
oral
Other Names:
  • MMF
EXPERIMENTAL: 2
oral
Drug: tacrolimus
immunosuppression
Other Names:
  • Prograf
  • FK506
Drug: mycophenolate mofetil
oral
Other Names:
  • MMF
Drug: steroids
oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Calculated creatinine clearance
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute Rejection, patient survival, graft survival
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (ACTUAL)

March 1, 2008

Study Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

May 1, 2006

First Submitted That Met QC Criteria

May 1, 2006

First Posted (ESTIMATE)

May 3, 2006

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG-506-02-IT-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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