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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 142
- Primary Endpoint
- Calculated creatinine clearance
Study 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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Drug)
1
oral
Intervention: mycophenolate mofetil (Drug)
2
oral
Intervention: tacrolimus (Drug)
2
oral
Intervention: mycophenolate mofetil (Drug)
2
oral
Intervention: steroids (Drug)
Outcomes
Primary Outcomes
Calculated creatinine clearance
Time Frame: 6 months
Secondary Outcomes
- Acute Rejection, patient survival, graft survival(6 months)