Table 1 Selection criteria

1

Patients who are males or non-pregnant females between the ages of 0 and 16 years.

2

Patients 4 weeks after kidney Tx.

3

Patients who received their first or second Tx 4 weeks ago.

4

Patients who are single-organ recipients.

5

If patients are women of childbearing potential, they must have a negative serum pregnancy test with a sensitivity equal to at least 50 mIU/ml before Tx.

6

If patients are women of childbearing potential, they must use an effective form of contraception such as the birth control pill (except mini-pill), hormonal depot injection, contraceptive hormonal patches, implanon, contraceptive hormone-containing coil or hormone-containing contraceptive vaginal ring, unless abstinence is the chosen method. In case of medical contraindication concerning the hormonal contraception, an intrauterine coil with a second contraceptive method (condom, diaphragm, spermicide) can be used. Effective contraception must be used before Tx, during therapy, and for 6 weeks following discontinuation of immunosuppressive therapy.

7

Patients’ guardians must be capable of understanding the purpose and risks of the study.

8

Patients whose guardians are willing to give written informed consent and willing to participate in and comply with the study protocol. Patients above 7 years have to agree with the study in addition to the informed consent of the legally authorized representative.

Exclusion criteria

1

Patients participating in other studies or participated within the last 4 weeks before study start.

2

Patients who are highly sensitized.

3

Patients who have undergone two organ transplantations previous to the current kidney Tx (that is, two kidney transplantations, two liver transplantations, kidney and liver, or kidney and pancreas transplantation).

4

Hypersensitivity to any of the components of the medication used.

5

Patients from other centers who are not followed in the outpatient unit of the Hannover Medical School or corresponding participating centers.

6

Patients with a peak or current panel reactive antibodies >50 %.

7

Pregnant and/or lactating women and women of childbearing potential who are unwilling or unable to use contraception methods as specified.

8

Patients whose guardians do not understand the requirements of the study.

9

Patients with known positive HIV-1 or Hepatitis C virus test or the presence of Hepatitis B surface antigen.

10

Patients with malignancies or history of malignancy, despite post-transplant lymphoproliferative disease.

11

Patients who are not eligible in the opinion of the physician.

12

Significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient’s safety, compliance, or study evaluations, according to the investigator’s opinion.