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
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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