NL-OMON51392尚未招募4 期
Personalized tacrolimus treatment for pediatric kidney transplant recipients by using a dosing algorithm and a once-daily tacrolimus formulation. - TACKI (Tacrolimus dosing in children with donor kidney)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 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
- 2 至 17（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •- 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
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- 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
- •Extra exclusion criteria for participation in study part B:
- •- Children who are not able to swallow a once-daily tacrolimus capsule
- •- 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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