2026-527107-22-00招募中4 期
ACTOR – AUC Control of Tacrolimus in Organ Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC0-12 (rich sampled)
研究概览
简要总结
To investigate whether AUC-guided tacrolimus dosing results in a greater proportion of patients achieving individualized therapeutic AUC0-12 targets 8 weeks after transplantation compared to standard C0-guided dosing
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •De novo kidney transplant recipient of standard immunological risk
- •Immunosuppressive drug regimen containing Prograf® (tacrolimus) used twice daily
- •Above 18 years of age
- •Able to comply with medical treatment on their own
- •Able to provide signed, informed consent
排除标准
- •Hypersensitivity to the active substances or any of the excipients of the study drugs.
- •Women who are breastfeeding, pregnant, or women of childbearing potential (WOCBP) not on highly effective contraception
研究组 & 干预措施
PROGRAF 1 mg capsule
Test
干预措施: PROGRAF 1 mg capsule (Drug)
结局指标
主要结局
AUC0-12 (rich sampled)
AUC0-12 (rich sampled)
次要结局
- AUC0-12 (limited sampling, 3 points)
- intra-individual coefficient of variation (CV%) of the AUC0-12/C0 ratio
- microbiome metagenomics
研究者
Anders Åsberg
Scientific
Oslo Universitetssykehus HF
研究点 (1)
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