Population Pharmacokinetics of Tacrolimus in Nephrotic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-10

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Nephrotic Syndrome Tacrolimus Pharmacokinetics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Tacrolimus

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

Intervention Type DRUG

Eligibility Criteria

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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。

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No