Kidney Transplantation Clinical Trial
Official title:
Precision Drug Use of Immunosuppressants Guided by Population Pharmacokinetics/Pharmacodynamic Models in Kidney Transplant Patients
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated Hospital of Chongqing Medical University | Chongqing |
Lead Sponsor | Collaborator |
---|---|
The Second Affiliated Hospital of Chongqing Medical University |
China,
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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