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临床试验/CTIS2024-511585-36-00
CTIS2024-511585-36-00进行中(未招募)1 期

Personalized tacrolimus treatment for pediatric kidney transplant recipients by using a dosing algorithm and a once-daily tacrolimus formulation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)0 个研究点目标入组 28 人开始时间: 2024年6月13日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
28

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
0 至 17(—)
性别
All

入选标准

  • Age 2-18 years old, Patients to be transplanted with a kidney allograft, Patients receiving a kidney from a blood group ABO-compatible donor, Patients who will receive tacrolimus as part of their initial immunosuppressive therapy, Signed written informed consent.

排除标准

  • Recipients of a non-renal organ transplant at the same occasion, Recipients of a blood group ABO-incompatible kidney allograft, Recipients of an HLA-incompatible kidney allograft (positive cross-match), Recipients receiving tacrolimus as immunosuppressive treatment within the preceding 28 days., Recipients using medication known to have a pharmacokinetic (drug-drug) interaction with tacrolimus (see Appendix I, table 1 for specification)., Extra exclusion criteria for participation in study part B: Children who are not able to swallow a once-daily tacrolimus capsule, Extra exclusion criteria for participation in study part B: Children with changes in the administration of drugs interacting with tacrolimus around the switch to the once-daily formulation.

研究者

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