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

Astellas Pharma Inc142 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

142

Conditions

KIDNEY TRANSPLANTATION

Interventions

tacrolimusDRUG

immunosuppression

mycophenolate mofetilDRUG

oral

steroidsDRUG

oral

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (14)

Unnamed facility

Bologna, Italy

Unnamed facility

Cagliari, Italy

Unnamed facility

Milan, Italy

Unnamed facility

Modena, Italy

Outcomes

Primary Outcomes

Calculated creatinine clearance

Time frame: 6 months

Secondary Outcomes

Acute Rejection, patient survival, graft survival

Time frame: 6 months

Data from ClinicalTrials.gov

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