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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00321113

Acronym

TIGRE

Enrollment

142

Registered

2006-05-03

Start date

2004-09-30

Completion date

2008-03-31

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

KIDNEY TRANSPLANTATION

Keywords

MARGINAL KIDNEY, TACROLIMUS, IMMUNOSUPPRESSION, ELDERLY RECEPIENTS

Brief summary

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.

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)

Interventions

DRUGtacrolimus

immunosuppression

DRUGmycophenolate mofetil

oral

DRUGsteroids

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Calculated creatinine clearance	6 months

Secondary

Measure	Time frame
Acute Rejection, patient survival, graft survival	6 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026