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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05872815
• Other study ID #: 2023-50
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Immunosuppressive Agents
• Kidney Transplantation

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