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| Name | Class |
|---|---|
| Hunan Provincial People's Hospital | OTHER |
| ZhuZhou Central Hospital | OTHER |
| First People's Hospital of Chenzhou | OTHER |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | Tacrolimus, oral, 0.05-0.075 mg/kg/d, Q12h, 6~12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Genotypes as measured by next generation sequencing | Genotypes as measured by next generation sequencing | one week |
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Inclusion Criteria:
(1)Patients with Nephrotic Syndrome:
(2)18-75years old(include 75),gender is not limited;
(3)Voluntary signing informed consent。
Exclusion Criteria:
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Patients with Nephrotic Syndrome are suit for use of Tacrolimus.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZHIJUN HUANG, Dr. | Contact | 073188618339 | huangzj@csu.edu.cn | |
| BIN YI, Dr. | Contact | 073188618210 | yibin_yb@163.com |
| Name | Affiliation | Role |
|---|---|---|
| ZHIJUN HUANG, Dr. | The Third Xiangya Hospital of Central South University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30719576 | Background | 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. | |
| 29637588 | Background | 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. |
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We welcomes researchers interested in collaboration. We request a short research proposal including information on the background, research questions and methods, timetable and budget, and authorship. For more information please contact the principal investigator.
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| ID | Term |
|---|---|
| D009404 | Nephrotic Syndrome |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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biospecific nonspecimen specimen will be collected for the PK analysis of Tacrolimus and the gene information of Cytochrome P450 3A (CYP3A)
| 22895519 | Background | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |