Pharmacokinetics Clinical Trial
— PISTONSOfficial title:
Population Pharmacokinetics of Tacrolimus for Optimal Dose in Patients With Nephrotic Syndrome
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.
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? |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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The Third Xiangya Hospital of Central South University | First People's Hospital of Chenzhou, Hunan Provincial People's Hospital, ZhuZhou Central Hospital |
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
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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