EUCTR2009-012436-32-DE进行中（未招募）1 期
A multicenter, randomized, open-labeled study to steer immunsuppressive 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.An explorative study. - Everolimus-IVIST
Medizinische Hochschule Hannover0 个研究点目标入组 64 人开始时间: 2009年7月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients who are males or non-pregnant females between the ages of 0 and 16 years.
- •2.Patients after kidney transplantation.
- •3.Patients who receive their first or second transplantation.
- •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 transplantation.
- •6.If patients are women of childbearing potential, they must use an effective form of contraception like birth control pill (except mini pill), hormonal depot injection, contraceptive hormonal patches, implanon, contraceptive hormone containing coil or hormon 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 (sondom, diaphragm, spermicide) can be used. Effective contraception must be used before transplantation, during therapy and for 6 weeks following discontinuation og 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 64
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients participating in other studies or participated within the last four weeks.
- •2.Patients who are highly sensitized.
- •3.Patients who have previously undergone two organ transplantations.
- •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 recruiting centers.
- •6.Patients with a peak or current PRA of >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 HCV test or the presence of HBsAg.
- •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.
研究者
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