Precision Drug Use of Immunosuppressants Guided by Population Pharmacokinetics/Pharmacodynamic Models in Kidney Transplant Patients

Recruiting

• Conditions: Kidney Transplantation; Immunosuppressive Agents

• Registration Number: NCT05872815
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-24
• Status Verified: 2023-08
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Drug plasma tough concentrations	Blood samples were collected 30minutes before administration	The tough concentrations of tacrolimus are as regard as the PK parameters
Immune factors levels(CD4+、CD8+、CD4+/CD8+、CD4+%、CD8+%)	The Immune factors levels were collected 30minutes before administration	The Immune factors levels are as regard as the PD parameters

Secondary Outcome Measures

Name	Time	Method
Clinical indicators	Follow-up after kidney transplantation was 6 months	Incidence of acute rejection,Incidence of tacrolimus adverse reactions and other advers are as regard as the PD parameters

Trial Locations

Locations (1)

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China