Population Pharmacokinetics of Tacrolimus in Nephrotic Syndrome

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04045171

Acronym

PISTONS

Enrollment

200

Registered

2019-08-05

Start date

2019-08-10

Completion date

2020-12-31

Last updated

2019-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrotic Syndrome, Pharmacokinetics, Tacrolimus

Keywords

Nephrotic Syndrome, Tacrolimus, Population Pharmacokinetics

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.

Interventions

DRUGTacrolimus

Tacrolimus, oral, 0.05-0.075 mg/kg/d, Q12h, 6～12 months

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* （1）Patients with Nephrotic Syndrome： 1. Proteinuria greater than 3.5 g/24 hour 2. Serum albumin \<30 g/l 3. Clinical evidence of peripheral oedema 4. 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。

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Genotypes as measured by next generation sequencing	one week	Genotypes as measured by next generation sequencing

Contacts

Primary ContactZHIJUN HUANG, Dr.

huangzj@csu.edu.cn073188618339

Backup ContactBIN YI, Dr.

yibin_yb@163.com073188618210

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026