Population Pharmacokinetics of Tacrolimus for Optimal Dose in Patients With Nephrotic Syndrome

The Third Xiangya Hospital of Central South University0 个研究点目标入组 200 人开始时间: 2019年8月10日最近更新: 2019年8月5日

适应症

试验速览

阶段: 不适用
发起方: The Third Xiangya Hospital of Central South University
入组人数: 200
主要终点: change of plasma concentration of Tacrolimus

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will use a multi-center, prospective design, with a "Real World Study" model, to include 200 patients with nephrotic syndrome. based on the Population Pharmacokinetics (PPK) model, it will study genotype and clinical factors in patients with nephrotic syndrome, to explore the Pharmacokinetics/ Pharmacodynamics (PK/PD) relationship of Tacrolimus in patients with nephrotic syndrome, and develop an optimal medication regimen.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•（1）Patients with Nephrotic Syndrome：
•Proteinuria greater than 3.5 g/24 hour
•Serum albumin <30 g/l
•Clinical evidence of peripheral oedema
•Hyperlipidemia 1) and 2) are necessary for diagnosis.
•（2）18-75years old（include 75），gender is not limited；
•（3）Voluntary signing informed consent。

排除标准

•（1）Secondary nephrotic syndrome；
•（2）Allergic to Tacrolimus or other unsuitable use of Tacrolimus；
•（3）With other immunosuppressive agents such as cyclosporin A, cyclophosphamide, mycophenolate mofetil, leflunomide, tripterygium wilfordii (hormone is not restricted)；
•（4）Severe liver dysfunction (transaminase > 3 ULN, or bilirubin > 3 ULN)；
•（5）Severe renal insufficiency（eGFR<30 ml/min/1.73m2）
•（6）Joined other clinical trials within 1 month；
•（7）Missing clinical data；
•（8）Pregnancy, lactation or planning for pregnancy within 12 months；
•（9）Researchers believe that patients who are not suitable for this clinical trial。

结局指标

主要结局

change of plasma concentration of Tacrolimus

时间窗: at 0hour，2hours，4hours，6hours，9hours，12hours after oral administration

Study the plasma concentration of Tacrolimus in patients with nephrotic syndrome

次要结局

Genotypes as measured by next generation sequencing(one week)

研究者

发起方

The Third Xiangya Hospital of Central South University

申办方类型

Other

责任方

Sponsor

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