PISTONS: Population Pharmacokinetics of Tacrolimus in Nephrotic Syndrome

Sponsor

The Third Xiangya Hospital of Central South University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04045171

Collaborator

Hunan Provincial People's Hospital (Other), ZhuZhou Central Hospital (Other), First People's Hospital of Chenzhou (Other)

200

Enrollment

16.7

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nephrotic Syndrome Tacrolimus Pharmacokinetics	Drug: Tacrolimus

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 10, 2019

Anticipated Primary Completion Date :

Jul 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

change of plasma concentration of Tacrolimus [at 0hour，2hours，4hours，6hours，9hours，12hours after oral administration]
Study the plasma concentration of Tacrolimus in patients with nephrotic syndrome

Secondary Outcome Measures

Genotypes as measured by next generation sequencing [one week]
Genotypes as measured by next generation sequencing

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

（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。

Exclusion Criteria:

（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。