Comparison of ATG to Thymoglobuline in Renal Transplantation

Inclusion criteria

• Recipients, who are at least 18 years or older and have a high immunological risk defined by:

The presence of at least one donor-specific antibody (class I and/or II) detected and specified by flow-technology (FlowPRA and single antigen beads), which are

• For class I below the threshold of detection of a current CDC T-cell-/ and B-cell cross-match
• For class II below the threshold of detection of a current CDC B-cell cross-match.
• Patient receives a renal allograft only.
• Female patients of child bearing age agree to maintain effective birth control practice during the study.
• Patient has been fully informed and has given written or independent person witnessed oral informed consent.

Exclusion criteria

• Patient is pregnant or breastfeeding.
• Patient has a low immunological risk constellation, defined by receiving a kidney from a HLA-identical related living donor.
• Patient and donor have a positive T-cell crossmatch.
• Patient and donor are ABO incompatible.
• Patient with combined transplantation.
• Age of donor >75 years.
• Cold ischemia time >40 hours.
• Patient has leucopenia, defined as having at transplantation less than 3000/mm3 leukocytes.
• Patient has thrombocytopenia, defined as having at transplantation less than 75000/mm3 thrombocytes.
• Patient is allergic or intolerant to ATG-Fresenius S, Thymoglobulin, steroids, Tacrolimus or MMF.
• EBV risk constellation (recipient EBV negative and donor EBV positive).
• Patient or donor is known to be HIV positive.
• Patient has a liver disease, defined as continuously having ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3fold of the upper value of the normal range of the investigational site during the past 28 days.
• Patient with malignancy or history of malignancy <2 years, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
• Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer.
• Patient is unlikely to comply with the visits schedule in the protocol.