Clinical trial NCT05872815: Precision Drug Use of Immunosuppressants Guided by Population Pharmacokinetics/Pharmacodynamic Models in Kidney Transplant Patients
Official title: Precision Drug Use of Immunosuppressants Guided by Population Pharmacokinetics/Pharmacodynamic Models in Kidney Transplant Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplantation
Immunosuppressive Agents
Keywords: Population pharmacokinetics/pharmacodynamics
Immunosuppressive Agents
Kidney transplantation
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All of the included population was kidney transplant patients,and all of they used triple immunosuppressant (tacrolimus + mycophenolate mofetil + glucocorticoids) for anti-rejection therapy,the results of laboratory could be collected.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Drug plasma tough concentrations
timeFrame: Blood samples were collected 30minutes before administration
measure: Immune factors levels(CD4+、CD8+、CD4+/CD8+、CD4+%、CD8+%)
timeFrame: The Immune factors levels were collected 30minutes before administration
Secondary outcomes:
measure: Clinical indicators
timeFrame: Follow-up after kidney transplantation was 6 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
Study officials:
References: