Kidney TransplantationNCT05872815
Precision Drug Use of Immunosuppressants Guided by Population Pharmacokinetics/Pharmacodynamic Models in Kidney Transplant Patients
An observational study of Kidney Transplantation and Immunosuppressive Agents, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplantation, Immunosuppressive Agents
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients undergoing kidney transplantation for the first time.
- Anti-rejection therapy with triple immunosuppressant (tacrolimus + mycophenolate mofetil + glucocorticoids).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
About this study
- 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;
- 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.
- Clarify the value of precision medicine guided by population pharmacokinetics/pharmacodynamics models in clinical practice.
Read the 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.
- Conditions
- Kidney Transplantation, Immunosuppressive Agents
- Keywords
- Population pharmacokinetics/pharmacodynamics, Immunosuppressive Agents, Kidney transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug plasma tough concentrations
The tough concentrations of tacrolimus are as regard as the PK parameters
Measured: 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
Measured: The Immune factors levels were collected 30minutes before administration
Secondary outcomes (1)
Clinical indicators
Incidence of acute rejection,Incidence of tacrolimus adverse reactions and other advers are as regard as the PD parameters
Measured: Follow-up after kidney transplantation was 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Jul 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872815
- Sponsor's protocol ID
- 2023-50
- Status last verified
- Aug 2023
- First submitted
- 19 Apr 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Drug Use of Immunosuppressants Guided by Population Pharmacokinetics/Pharmacodynamic Models in Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT05872815
- Acronym / sponsor ID
- 2023-50
- Conditions
- Kidney Transplantation, Immunosuppressive Agents
- Keywords
- Population pharmacokinetics/pharmacodynamics, Immunosuppressive Agents, Kidney transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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;
- 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.
- 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 design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients undergoing kidney transplantation for the first time.
- Anti-rejection therapy with triple immunosuppressant (tacrolimus + mycophenolate mofetil + glucocorticoids).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Drug plasma tough concentrations
Time frame: 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+%)
Time frame: The Immune factors levels were collected 30minutes before administration
The Immune factors levels are as regard as the PD parameters
1 secondary outcome
Clinical indicators
Time frame: Follow-up after kidney transplantation was 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and Immunosuppressive Agents, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Xian (18512356862, 1clinicaltrial@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug plasma tough concentrations (time frame: Blood samples were collected 30minutes before administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.