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

NCT05872815 | Unknown

• 1 other identifier: 2023-50
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.Clarify the value of precision medicine guided by population pharmacokinetics/pharmacodynamics models in clinical practice.

Conditions

Kidney Transplantation; Immunosuppressive Agents

Keywords

Population pharmacokinetics/pharmacodynamics; Immunosuppressive Agents; Kidney transplantation

Outcome Measures

Primary Outcomes (2)

• Drug plasma tough concentrations

  The tough concentrations of tacrolimus are as regard as the PK parameters

  Blood samples were collected 30minutes before administration

• 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 Outcomes (1)

• Clinical indicators

  Follow-up after kidney transplantation was 6 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients undergoing kidney transplantation for the first time.
• Anti-rejection therapy with triple immunosuppressant (tacrolimus + mycophenolate mofetil + glucocorticoids).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

Central Study Contacts

Yu Xian

CONTACT

18512356862; 1clinicaltrial@hospital.cqmu.edu.cn

Xiang Qiulin

CONTACT

18716938270; xql1844025147@163.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 24, 2023
• Study Start: July 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-08

Locations

CN (1)