NCT04045171

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

August 10, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

12 months

First QC Date

July 31, 2019

Last Update Submit

August 2, 2019

Conditions

Nephrotic SyndromeTacrolimusPharmacokinetics

Keywords

Nephrotic SyndromeTacrolimusPopulation Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Genotypes as measured by next generation sequencing

    one week

Interventions

TacrolimusDRUG

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Nephrotic Syndrome are suit for use of Tacrolimus.

You may qualify if:

  • （1）Patients with Nephrotic Syndrome：
  • Proteinuria greater than 3.5 g/24 hour
  • Serum albumin \<30 g/l
  • Clinical evidence of peripheral oedema
  • Hyperlipidemia 1) and 2) are necessary for diagnosis.
  • （2）18-75years old（include 75），gender is not limited；
  • （3）Voluntary signing informed consent。

You may not qualify if:

  • （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。

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 30719576BACKGROUND

  • 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.

    PMID: 29637588BACKGROUND

  • 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.

    PMID: 22895519BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

biospecific nonspecimen specimen will be collected for the PK analysis of Tacrolimus and the gene information of Cytochrome P450 3A (CYP3A)

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • ZHIJUN HUANG, Dr.

    The Third Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ZHIJUN HUANG, Dr.

CONTACT

073188618339huangzj@csu.edu.cn

BIN YI, Dr.

CONTACT

073188618210yibin_yb@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 5, 2019

Study Start

August 10, 2019

Primary Completion

July 31, 2020

Study Completion

December 31, 2020

Last Updated

August 5, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

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.