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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05872815
Other study ID # 2023-50
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date July 1, 2024

Study information

Verified date August 2023
Source The Second Affiliated Hospital of Chongqing Medical University
Contact Yu Xian
Phone 18512356862
Email 1clinicaltrial@hospital.cqmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. Construct a population pharmacokinetic/pharmacodynamic model of tacrolimus in kidney transplant patients, and explore the quantitative relationship between combination drugs and gene polymorphisms on the safety and efficacy of tacrolimus in kidney transplant patients; 2. Based on the established pharmacokinetic/pharmacodynamic model of tacrolimus population in kidney transplant patients, combined with combined drugs, gene polymorphisms and other factors for simulation, predict the steady-state trough concentration and efficacy of tacrolimus in kidney transplant patients taking triple drugs (tacrolimus, mycophenolate mofetil/mycophenol sodium enteric-coated tablets, glucocorticoids), and apply the model to the real world to explore the optimal initial dose and maintenance therapeutic dose of tacrolimus, so as to achieve individualized and precise treatment and guide the rational clinical use of drugs. 3. Clarify the value of precision medicine guided by population pharmacokinetics/pharmacodynamics models in clinical practice.


Description:

This is a retrospective study. It is proposed to combine the classical basic principles of pharmacokinetics with mathematical statistical models, and use nonlinear mixed effect model (NONMEM) or other population pharmacokinetics/pharmacodynamics software to establish a population pharmacokinetic/pharmacodynamic model of tacrolimus in kidney transplant patients, and elucidate the combination of drugs, demographic factors, pathophysiological factors, genotype, The quantitative effect of comorbid diseases and drugs on the steady-state trough concentration and efficacy of tacrolimus in kidney transplant patients, so as to realize individualized and precise treatment of kidney transplant patients through model simulation and prediction of steady-state trough concentration and efficacy after taking drugs.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients undergoing kidney transplantation for the first time. - Anti-rejection therapy with triple immunosuppressant (tacrolimus + mycophenolate mofetil + glucocorticoids). Exclusion Criteria: - The patient's medication status is unclear and there is a lack of relevant results of laboratory test indicators. - The patient has undergone multi-organ or combined liver and kidney transplantation or has a history of liver and kidney transplantation. - Transplantation failure or death.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China The Second Affiliated Hospital of Chongqing Medical University Chongqing

Sponsors (1)

Lead Sponsor Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Drug plasma tough concentrations The tough concentrations of tacrolimus are as regard as the PK parameters Blood samples were collected 30minutes before administration
Primary Immune factors levels(CD4+?CD8+?CD4+/CD8+?CD4+%?CD8+%) The Immune factors levels are as regard as the PD parameters The Immune factors levels were collected 30minutes before administration
Secondary Clinical indicators Incidence of acute rejection,Incidence of tacrolimus adverse reactions and other advers are as regard as the PD parameters Follow-up after kidney transplantation was 6 months
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