Population Pharmacokinetics of Tacrolimus in Nephrotic Syndrome (PISTONS)

Central South University

Status: Unknown

Conditions: Tacrolimus; Pharmacokinetics; Nephrotic Syndrome

Treatments: Drug: Tacrolimus

Study type: Observational

Funder types: Other

Identifiers

NCT04045171

XY3-IIT-TAC1905A01

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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。