Individually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study (CD4-01)

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.