Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
893
Glomerular filtration rate (GFR) at 24 Weeks after transplantation estimated using the MDRD4 formula
Time frame: 24 weeks
Incidence of and time to first incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)
Time frame: 24 weeks
GFR at 24 Weeks after transplantation measured by Iothalamate clearance
Time frame: 24 weeks
GFR at 24 Weeks after transplantation estimated using a Cystatin C based formula
Time frame: 24 weeks
Creatinine clearance at 24 Weeks after transplantation estimated using the Cockcroft and Gault formula
Time frame: 24 weeks
Incidence of and time to first incidence of acute rejection
Time frame: 24 weeks
Incidence of and time to first incidence of corticosteroid-resistant acute rejection
Time frame: 24 weeks
Overall frequency of acute rejection episodes
Time frame: 24 weeks
Incidence of and time to first incidence of biopsy confirmed acute rejection
Time frame: 24 weeks
Incidence of and time to first incidence of biopsy confirmed corticosteroid-resistant acute rejection
Time frame: 24 weeks
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IV bolus
160
Buenos Aires, Argentina
001
Innsbruck, Austria
146
Minsk, Belarus
008
Brussels, Belgium
006
Ghent, Belgium
009
Leuven, Belgium
010
Liège, Belgium
163
São Paulo, Brazil
153
Edmonton, Canada
150
Halifax, Canada
...and 62 more locations
Overall frequency of biopsy confirmed acute rejection episodes
Time frame: 24 weeks
Severity of biopsy confirmed acute rejection episodes
Time frame: 24 weeks