Population Pharmacokinetics of Tacrolimus in Nephrotic Syndrome

Overview

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.

Full Title of Study: “Population Pharmacokinetics of Tacrolimus for Optimal Dose in Patients With Nephrotic Syndrome”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 31, 2020

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • change of plasma concentration of Tacrolimus
    • Time Frame: at 0hour,2hours,4hours,6hours,9hours,12hours after oral administration
    • Study the plasma concentration of Tacrolimus in patients with nephrotic syndrome

Secondary Measures

  • Genotypes as measured by next generation sequencing
    • Time Frame: one week
    • Genotypes as measured by next generation sequencing

Participating in This Clinical Trial

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。

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Third Xiangya Hospital of Central South University
  • Collaborator
    • Hunan Provincial People’s Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • ZHIJUN HUANG, Dr., Principal Investigator, The Third Xiangya Hospital of Central South University
  • Overall Contact(s)
    • ZHIJUN HUANG, Dr., 073188618339, huangzj@csu.edu.cn

References

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.

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.

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.

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