Individually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study
Inclusion Criteria:
- First or second kidney transplantation
- Males and females, 18 years old or older
- Women of childbearing potential must have a negative serum or urine pregnancy test
with sensitivity equal to at least 50 mIU/mL
- Patients must be capable of understanding the purpose and risks of the study and must
sign an informed consent form
Exclusion Criteria:
- Multiple organ transplantation (eg. kidney-pancreas, kidney-heart, kidney-liver,...)
- Transplantation of a patient who received another organ transplant previously except
one kidney transplant
- Recipients of HLA-identical living-related renal transplants
- Patients with PRA > 10%, patients who have lost a first graft from rejection.
- Pregnant or lactating women
- WBC =< 2.5 x 109/L (IU), platelet count =< 100 x 109/L (IU), or Hb =< 6g/dl at the
time of entry into the study
- Active peptic ulcer
- Severe diarrhea or other gastrointestinal disorders which might interfere with the
ability to absorb oral medication, including diabetic patients with previously
diagnosed diabetic gastroenteropathy
- Known HIV-1 or HTLV-1 positive tests
- History of malignancy in the past 5 years (with the exception of adequately treated
basal or squamous skin cell carcinoma)
- The use of investigational drugs or other immunosuppressive drugs as those specified
in this protocol
- Patients receiving bile acid sequestrants
- Psychological illness or condition interfering with the patient's compliance or
ability to understand the requirements of the study.