This study is an open, randomised trial in which one group of patients (control) will receive the golden standard therapy and the other group (treatment) will receive individually adapted immunosuppression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
individual adapted immunosuppression
golden standard therapy
University Hospital Ghent
Ghent, Belgium
Graft function as measured by Cr EDTA AUC
Time frame: at 1 year
Graft survival
Time frame: at 1 year
Patient survival
Time frame: at 1 year
Graft function measured by estimated GFR (eGFR) (MDRD and Cockroft-Gault)
Time frame: at 1 year
Frequency of biopsy proven acute rejection episodes
Time frame: at 1 year
Incidence of biopsy proven acute rejection (BPAR) and clinical (non-biopsy proven) acute rejection episodes treated by a full course anti-rejection therapy (e.g. steroids) (Treatment of rejection according to center practice).
Time frame: at 1 year
Incidence of rejection treated by antibodies (OKT3, ATG)
Time frame: at 1 year
Time to first rejection (days)
Time frame: at 1 year
Severity of rejection as assessed by BANFF 2005 score
Time frame: at 1 year
Number of acute rejections per patient
Time frame: at 1 year
Plasma creatinine and eGFR
Time frame: at month 1, 3 and yearly (2 and 3 years)
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Measured GFR
Time frame: at month 3 and yearly
Proteinuria
Time frame: at month 1, 3 and at 1 and 3 years
Incidence and score of borderline changes and acute rejection
Time frame: in month 3 and month 12 biopsy
Incidence and score of chronic alloimmune injury/rejection and nonimmune injury
Time frame: in month 3 and month 12 biopsies (BANFF 2005)
Development and evolution of glucose abnormalities
Time frame: at 1 year
blood pressure
Time frame: at 1 year
ambulatory 24-hr blood pressure monitoring
Time frame: at 1 year and 3 years
Left ventricular mass assessed by echocardiography
Time frame: at 1 year and 3 years
Fasting lipid profile
Time frame: at baseline, month 1,3,6 and yearly
CMV infection (as measured with whole blood PCR) and disease
Time frame: at 1 year
Polyoma virus replication as measured by whole blood PCR
Time frame: at 1 year
Incidence of BK nephritis
Time frame: in month 3 and month 12 biopsies
Incidence of PTLD and Nonmelanoma skin cancer
Time frame: at 1 year and yearly
Incidence of EBV reactivation (as measured with whole blood PCR)
Time frame: at 1 year and yearly