Clinical trial NCT00321113: Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: KIDNEY TRANSPLANTATION
Keywords: MARGINAL KIDNEY
TACROLIMUS
IMMUNOSUPPRESSION
ELDERLY RECEPIENTS
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 142
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Calculated creatinine clearance
timeFrame: 6 months
Secondary outcomes:
measure: Acute Rejection, patient survival, graft survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Bologna
country: Italy
city: Cagliari
country: Italy
city: Milano
country: Italy
city: Modena
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Sassari
country: Italy
city: Siena
country: Italy
city: Treviso
country: Italy
city: Udine
country: Italy
city: Vicenza
country: Italy
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Medical Director
role: STUDY_DIRECTOR
References: