Population Pharmacokinetics of Tacrolimus in Nephrotic Syndrome

• Conditions: Nephrotic Syndrome; Tacrolimus; Pharmacokinetics

• Registration Number: NCT04045171
• Lead Sponsor: The Third Xiangya Hospital of Central South University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-31
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-02
• Last Update Submitted: 2019-08-02
• Study First Posted: 2019-08-05
• Last Update Posted: 2019-08-05
• Study Start: 2019-08-10
• Primary Completion: 2020-07-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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。

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Genotypes as measured by next generation sequencing	one week	Genotypes as measured by next generation sequencing