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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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KIDNEY TRANSPLANTATION

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

oral

Group Type ACTIVE_COMPARATOR

tacrolimus

Intervention Type DRUG

immunosuppression

mycophenolate mofetil

Intervention Type DRUG

oral

2

oral

Group Type EXPERIMENTAL

tacrolimus

Intervention Type DRUG

immunosuppression

mycophenolate mofetil

Intervention Type DRUG

oral

steroids

Intervention Type DRUG

oral

Interventions

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tacrolimus

immunosuppression

Intervention Type DRUG

mycophenolate mofetil

oral

Intervention Type DRUG

steroids

oral

Intervention Type DRUG

Other Intervention Names

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Prograf FK506 MMF

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No