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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04045171
Other study ID # XY3-IIT-TAC1905A01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 10, 2019
Est. completion date December 31, 2020

Study information

Verified date August 2019
Source The Third Xiangya Hospital of Central South University
Contact ZHIJUN HUANG, Dr.
Phone 073188618339
Email huangzj@csu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 31, 2020
Est. primary completion date July 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Intervention

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

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
The Third Xiangya Hospital of Central South University First People's Hospital of Chenzhou, Hunan Provincial People's Hospital, ZhuZhou Central Hospital

References & Publications (3)

Hao GX, Huang X, Zhang DF, Zheng Y, Shi HY, Li Y, Jacqz-Aigrain E, Zhao W. Population pharmacokinetics of tacrolimus in children with nephrotic syndrome. Br J Clin Pharmacol. 2018 Aug;84(8):1748-1756. doi: 10.1111/bcp.13605. Epub 2018 May 22. — View Citation

Lu T, Zhu X, Xu S, Zhao M, Huang X, Wang Z, Zhao L. Dosage Optimization Based on Population Pharmacokinetic Analysis of Tacrolimus in Chinese Patients with Nephrotic Syndrome. Pharm Res. 2019 Feb 4;36(3):45. doi: 10.1007/s11095-019-2579-6. — View Citation

Radhakrishnan J, Cattran DC. The KDIGO practice guideline on glomerulonephritis: reading between the (guide)lines--application to the individual patient. Kidney Int. 2012 Oct;82(8):840-56. doi: 10.1038/ki.2012.280. Epub 2012 Aug 15. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary change of plasma concentration of Tacrolimus Study the plasma concentration of Tacrolimus in patients with nephrotic syndrome at 0hour,2hours,4hours,6hours,9hours,12hours after oral administration
Secondary Genotypes as measured by next generation sequencing Genotypes as measured by next generation sequencing one week
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