Using pharmacokinetics to personalize immunosuppressant treatment in kidney transplant patients
Precision Drug Use of Immunosuppressants Guided by Population Pharmacokinetics/Pharmacodynamic Models in Kidney Transplant Patients
This study is testing how to personalize the dosing of a key medication for kidney transplant patients to make sure it works better and is safer for each individual.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Sex | All |
| Sponsor | The Second Affiliated Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing) |
| Trial ID | NCT05872815 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a population pharmacokinetic/pharmacodynamic model for tacrolimus in kidney transplant patients. It will analyze the effects of combination drugs and genetic factors on the drug's safety and efficacy. By simulating various scenarios, the study seeks to predict optimal dosing strategies for tacrolimus, enhancing individualized treatment approaches for patients undergoing kidney transplantation. The ultimate goal is to guide clinicians in the rational use of immunosuppressive therapy based on precise pharmacological data.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing their first kidney transplantation who will receive a triple immunosuppressant regimen.
Not a fit: Patients with unclear medication statuses, those who have undergone multi-organ transplants, or those with transplant failure or death may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized immunosuppressant regimens for kidney transplant patients, improving their outcomes.
How similar studies have performed: Other studies have shown promise in using pharmacokinetic models for drug dosing in transplant patients, suggesting this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chongqing
- The Second Affiliated Hospital of Chongqing Medical University — Chongqing, China (Recruiting)
Study contacts
- Study coordinator: Yu Xian
- Email: 1clinicaltrial@hospital.cqmu.edu.cn
- Phone: 18512356862
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.