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Table 1 Selection criteria

From: A multicenter, randomized, open-labeled study to steer immunosuppressive and antiviral therapy by measurement of virus (CMV, ADV, HSV)-specific T cells in addition to determination of trough levels of immunosuppressants in pediatric kidney allograft recipients (IVIST01-trial): study protocol for a randomized controlled trial

Inclusion 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.
  1. Tx, transplantation.