Recruitment became very slow.

The main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept® or Myfortic®/TAC and without corticosteroids and a treatment consisting of CellCept® or Myfortic®/TAC and corticosteroids during the first year after renal transplantation.

Inclusion Criteria

• Signed and dated informed consent form,
• End-stage renal disease,
• Candidates for a first transplantation,
• Re-transplant patients are eligible if a graft loss after transplantation was NOT due to immunological reasons,
• Availability of a heart-beating cadaveric donor up to 70 years of age with a cold ischemia time shorter than 36 hours,
• Male or female patients between 18 to 75 years of age inclusive,
• Patients able to comply with all study related requirements,
• Patients able to receive oral medication,
• Women of childbearing age with a safe contraceptive method throughout the study.

Exclusion Criteria

• Women who are pregnant or breast feeding,
• Known Human Immunodeficiency Virus,
• Hepatitis B Virus or Hepatitis C Virus infection,
• Severe actual viral, bacterial or fungal infection not adequately controlled,
• Patients with anamnestically known hypersensitivity to rabbit immunoglobulin antibodies or positive rabbit immunoglobulin skin test or known allergies to any component of the immunosuppressive drugs per protocol,
• Patients at high immunological risk defined as current PRA > 25% or historical PRA > 50%,
• Patients receiving pre-transplant immunosuppressive treatment, including corticosteroids,
• Patients with current or history of malignancies (exception basal cell carcinoma or squamous cell carcinoma in remission),
• Patients with previous transplantation except 1st graft loss due to surgical complications,
• Patients receiving combined transplantation,
• Patients with major organ dysfunctions,
• Serious psychiatric or psychological disorders,
• Pre-transplant thrombocytopenia: < 50,000 thrombocytes/µl, Pre-transplant leukopenia: < 2,000 leukocytes/µl,
• Unable or unwilling to comply fully with the protocol,
• Participation in another study of an investigational medicinal product concurrently or within the last 30 days.