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

Phase 3

Completed

• Conditions: KIDNEY TRANSPLANTATION
• Interventions: Drug: tacrolimus; Drug: mycophenolate mofetil; Drug: steroids

• Registration Number: NCT00321113
• Lead Sponsor: Astellas Pharma Inc

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)

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2006-05-01
• Study First Submitted QC: 2006-05-01
• Study First Posted: 2006-05-03
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	tacrolimus	oral
1	mycophenolate mofetil	oral
2	tacrolimus	oral
2	mycophenolate mofetil	oral
2	steroids	oral

Primary Outcome Measures

Name	Time	Method
Calculated creatinine clearance	6 months

Secondary Outcome Measures

Name	Time	Method
Acute Rejection, patient survival, graft survival	6 months