Population Pharmacokinetics of Tacrolimus in Nephrotic Syndrome

Pharmacokinetics Clinical Trial

— PISTONS  

Official title:

Population Pharmacokinetics of Tacrolimus for Optimal Dose in Patients With Nephrotic Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04045171
• Other study ID #: XY3-IIT-TAC1905A01
• Status: Not yet recruiting
• 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
• 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?

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Pharmacokinetics
• Syndrome
• Tacrolimus

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