Status:
UNKNOWN
Population Pharmacokinetics of Tacrolimus in Nephrotic Syndrome
Lead Sponsor:
The Third Xiangya Hospital of Central South University
Collaborating Sponsors:
Hunan Provincial People's Hospital
ZhuZhou Central Hospital
Conditions:
Nephrotic Syndrome
Tacrolimus
Eligibility:
All Genders
18-75 years
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 ...
Eligibility Criteria
Inclusion
- （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
- （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。
Key Trial Info
Start Date :
August 10 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04045171
Start Date
August 10 2019
End Date
December 31 2020
Last Update
August 5 2019
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