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
Overview
- Phase
- Phase 3
- Intervention
- tacrolimus
- Conditions
- KIDNEY TRANSPLANTATION
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 142
- Primary Endpoint
- Calculated creatinine clearance
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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)
Investigators
Eligibility Criteria
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
Arms & Interventions
1
oral
Intervention: tacrolimus
1
oral
Intervention: mycophenolate mofetil
2
oral
Intervention: tacrolimus
2
oral
Intervention: mycophenolate mofetil
2
oral
Intervention: steroids
Outcomes
Primary Outcomes
Calculated creatinine clearance
Time Frame: 6 months
Secondary Outcomes
- Acute Rejection, patient survival, graft survival(6 months)