The purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.
This study will evaluate the potential to reduce nephrotoxic calcineurin inhibitors (CNI) therapy by lowering tacrolimus exposure from Advagraf® in combination with the non-nephrotoxic immunosuppressant sirolimus to avoid the risk of acute graft rejection, compared with an Advagraf® and Mycophenolate Mofetil (MMF) immunosuppressive regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
853
Glomerular Filtration Rate (GFR) estimated by iohexol clearance at Week 52 post kidney transplantation
Time frame: up to 1 year
Efficacy failure
Composite endpoint defined as graft loss (re-transplantation, nephrectomy, death or dialysis ongoing at the study end) or subject withdrawal
Time frame: up to 1 year
GFR at Week 52 post kidney transplantation by Modification Diet in Renal Disease (MDRD) formula
Time frame: up to 1 year
GFR at Week 52 post kidney transplantation by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
Time frame: up to 1 year
Calculated creatinine clearance at Week 52 post kidney transplantation by Cockcroft and Gault formula
Time frame: up to 1 year
Incidence of clinical acute rejection
Time frame: up to 1 year
Time to clinical acute rejection
Time frame: up to 1 year
Incidence of Biopsy Confirmed Acute Rejection
Time frame: up to 1 year
Time to Biopsy Confirmed Acute Rejection
Time frame: up to 1 year
Subject survival
Time frame: up to 1 year
Graft survival
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i.v. and oral
5042
New Lambton, Australia
5043
Perth, Australia
1141
Innsbruck, Austria
1142
Linz, Austria
1140
Vienna, Austria
3240
Minsk, Belarus
1241
Leuven, Belgium
1240
Liège, Belgium
Site 1441
Brno, Czechia
1440
Ostrava - Poruba, Czechia
...and 48 more locations
Time frame: up to 1 year
New Onset Diabetes Mellitus (NODM) as per American Diabetic Association (ADA) criteria
Time frame: up to 1 year