Complete and Accurate Statistical Data of 60 PatientsNCT06319391
Analysis of the Effect of Donor CYP3A5 Gene Polymorphism on Early Tacrolimus Concentration and Postoperative Acute Renal Injury After Liver Transplantation
An observational study of Complete and Accurate Statistical Data of 60 Patients and CYP3A5*3 Genotypes of 60 Donors and Recipients Were Analyzed Accurately, run by Ziqiang Li at 1 site in China.
Trial summary
Tacrolimus is the most commonly used immunosuppressant for preventing and treating rejection after liver transplantation. However, its treatment window is narrow, the pharmacokinetic individual differences are large, routine dose according to body weight, sometimes low dose will cause graft rejection of patients, or… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Complete and Accurate Statistical Data of 60 Patients, CYP3A5*3 Genotypes of 60 Donors and Recipients Were Analyzed Accurately, Postoperative Tacrolimus Concentrations Were Accurately Recorded in 60 Patients
- What is being tested?
- CYP3A5*1*、CYP3A5*1*3 and CYP3A5*3*3
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 1 Oct 2025
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 60 patients receiving liver transplantation at the center of Qianfoshan Hospital in 2022.01-2023.06
Who may be able to join
- Patients undergoing orthotopic liver transplantation in our center.
- The postoperative immunosuppression regimen was tacrolimus、methylprednisolone and balipremumab for injection in all cases,and no drugs that interacted with tacrolimus were used.
- The postoperative follow-up time was greater than 6 months and no serious rejection occurred during the follow-up period.
Who cannot join
- Combined organ transplantation.
- liver transplant patients on other immunosuppressive regimens.
- Preoperative CKD or need RRT.
- Preoperative serum creatinine (SCr) > 133 mol/L.
- Loss of follow-ups.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
Jinan, Shandong, 250013
About this study
Tacrolimus is the most commonly used immunosuppressant for preventing and treating rejection after liver transplantation. However, its treatment window is narrow, the pharmacokinetic individual differences are large, routine dose according to body weight, sometimes low dose will cause graft rejection of patients, or high dose will lead to infection and liver and kidney toxicity and other adverse reactions. Moreover, the conventional drug testing can not fully reflect the efficacy of tacrolimus, and there are shortcomings of lag, experience and passivity. FK506 is metabolized primarily by cytochrome P450 member 3A5 in the liver and intestines. CYP3A5*3 is the most important factor determining the expression level of CYP3A5. This mutation can cause variable shear and produce unstable protein, so that patients carrying CYP3A5*3/*3 gene do not express CYP3A5. Acute kidney injury is a common and important complication after liver transplantation. Despite recent advances in organ preservation, surgical techniques, and immunosuppressive protocols, the incidence of AKI after orthotopic liver transplantation remains high. AKI has a significant impact on both short - and long-term prognosis of orthotopic liver transplantation recipients. Studies have shown that orthotopic liver transplantation recipients with AKI have significantly higher mortality rates in hospital, at 28 days and at 1 year after surgery than those without AKI. In this study, the relationship between donor and recipient CYP3A5 gene polymorphism and tacrolimus concentration was investigated, and the effect of donor and recipient CYP3A5 gene polymorphism and tacrolimus concentration on acute kidney injury after liver transplantation was investigated. To provide guidance for individual administration of gene-directed tacrolimus in patients, and provide basis for prevention and reduction of postoperative acute kidney injury in liver transplantation patients.
- Conditions
- Complete and Accurate Statistical Data of 60 Patients, CYP3A5*3 Genotypes of 60 Donors and Recipients Were Analyzed Accurately, Postoperative Tacrolimus Concentrations Were Accurately Recorded in 60 Patients, According to the Diagnosis and Grading Criteria of Acute Kidney Injury, the Cases and Grading of Postoperative Acute Kidney Injury in 60 Patients Were Counted, Scientific and Rigorous Statistical Analysis of Data
- Being tested
- CYP3A5*1*、CYP3A5*1*3, CYP3A5*3*3
- Keywords
- CYP3A5, gene polymorphism, tacrolimus, acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYP3A5*1*、CYP3A5*1*3Other
2ml of venous blood was drawn and placed in an EDTA anticoagulant tube. Peripheral blood genomic DNA was extracted according to the instructions of the DNA extraction kit.The reaction system was prepared by polymerase chain reaction (PCR) according to the instructions of PCR amplification system. After 25g/L agarose gel electrophoresis, the bands of amplified products were observed under UV lamp. The PCR products were purified by enzymolysis. The purified product was prepared according to sequencing PCR amplification system. After 1min predenaturation at 96℃, denaturation at 96℃ for 30s, annealing at 56 ℃ for 30s and extension at 72℃ for 1 cycle. A total of 25 cycles were performed for sequencing PCR amplification. The amplified products were purified by ethanol precipitation method.
CYP3A5*3*3Other
2ml of venous blood was drawn and placed in an EDTA anticoagulant tube. Peripheral blood genomic DNA was extracted according to the instructions of the DNA extraction kit.The reaction system was prepared by polymerase chain reaction (PCR) according to the instructions of PCR amplification system.After 25g/L agarose gel electrophoresis, the bands of amplified products were observed under UV lamp. The PCR products were purified by enzymolysis. The purified product was prepared according to sequencing PCR amplification system. After 1min predenaturation at 96℃, denaturation at 96℃ for 30s, annealing at 56 ℃ for 30s and extension at 72℃ for 1 cycle. A total of 25 cycles were performed for sequencing PCR amplification. The amplified products were purified by ethanol precipitation method.
| Study group | Role | What they receive |
|---|---|---|
| donor/acceptor expression group | Not described Receives: Other: CYP3A5*1*、CYP3A5*1*3 | |
| donor expression/acceptor non-expression | Not described | |
| donor non-expression/acceptor expression | Not described | |
| donor/acceptor non-expression group | Not described Receives: Other: CYP3A5*3*3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fk506
Tacrolimus concentration
Measured: 1-28 days postoperatively
Scr
Reflects indicators of kidney function
Measured: 1-28 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Apr 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete and Accurate Statistical Data of 60 PatientsStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziqiang Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ziqiang Li, Qianfoshan Hospital
- Investigators
- Liziqiang Liziqiang, Doctor, Study director, Party
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319391
- Sponsor's protocol ID
- JSZ007
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effect of Donor CYP3A5 Gene Polymorphism on Early Tacrolimus Concentration and Postoperative Acute Renal Injury After Liver Transplantation
- ClinicalTrials.gov ID
- NCT06319391
- Acronym / sponsor ID
- JSZ007
- Conditions
- Complete and Accurate Statistical Data of 60 Patients, CYP3A5*3 Genotypes of 60 Donors and Recipients Were Analyzed Accurately, Postoperative Tacrolimus Concentrations Were Accurately Recorded in 60 Patients, According to the Diagnosis and Grading Criteria of Acute Kidney Injury, the Cases and Grading of Postoperative Acute Kidney Injury in 60 Patients Were Counted, Scientific and Rigorous Statistical Analysis of Data
- Keywords
- CYP3A5, gene polymorphism, tacrolimus, acute kidney injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ziqiang LiUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 20 Mar 2024 (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.
Tacrolimus is the most commonly used immunosuppressant for preventing and treating rejection after liver transplantation. However, its treatment window is narrow, the pharmacokinetic individual differences are large, routine dose according to body weight, sometimes low dose will cause graft rejection of patients, or high dose will lead to infection and liver and kidney toxicity and other adverse reactions. Moreover, the conventional drug testing can not fully reflect the efficacy of tacrolimus, and there are shortcomings of lag, experience and passivity. FK506 is metabolized primarily by cytochrome P450 member 3A5 in the liver and intestines. CYP3A5*3 is the most important factor determining the expression level of CYP3A5. This mutation can cause variable shear and produce unstable protein, so that patients carrying CYP3A5*3/*3 gene do not express CYP3A5. Acute kidney injury is a common and important complication after liver transplantation. Despite recent advances in organ preservation, surgical techniques, and immunosuppressive protocols, the incidence of AKI after orthotopic liver transplantation remains high. AKI has a significant impact on both short - and long-term prognosis of orthotopic liver transplantation recipients. Studies have shown that orthotopic liver transplantation recipients with AKI have significantly higher mortality rates in hospital, at 28 days and at 1 year after surgery than those without AKI. In this study, the relationship between donor and recipient CYP3A5 gene polymorphism and tacrolimus concentration was investigated, and the effect of donor and recipient CYP3A5 gene polymorphism and tacrolimus concentration on acute kidney injury after liver transplantation was investigated. To provide guidance for individual administration of gene-directed tacrolimus in patients, and provide basis for prevention and reduction of postoperative acute kidney injury in liver transplantation patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| donor/acceptor expression group | – | Other: CYP3A5*1*、CYP3A5*1*3 |
| donor expression/acceptor non-expression | – | – |
| donor non-expression/acceptor expression | – | – |
| donor/acceptor non-expression group | – | Other: CYP3A5*3*3 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 60 patients receiving liver transplantation at the center of Qianfoshan Hospital in 2022.01-2023.06
Key inclusion criteria (3 listed)
- Patients undergoing orthotopic liver transplantation in our center.
- The postoperative immunosuppression regimen was tacrolimus、methylprednisolone and balipremumab for injection in all cases,and no drugs that interacted with tacrolimus were used.
- The postoperative follow-up time was greater than 6 months and no serious rejection occurred during the follow-up period.
Key exclusion criteria (5 listed)
- Combined organ transplantation.
- liver transplant patients on other immunosuppressive regimens.
- Preoperative CKD or need RRT.
- Preoperative serum creatinine (SCr) > 133 mol/L.
- Loss of follow-ups.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYP3A5*1*、CYP3A5*1*32ml of venous blood was drawn and placed in an EDTA anticoagulant tube. Peripheral blood genomic DNA was extracted according to the instructions of the DNA extraction kit.The reaction system was prepared by polymerase chain reaction (PCR) according to the instructions of PCR amplification system. After 25g/L agarose gel electrophoresis, the bands of amplified products were observed under UV lamp. The PCR products were purified by enzymolysis. The purified product was prepared according to sequencing PCR amplification system. After 1min predenaturation at 96℃, denaturation at 96℃ for 30s, annealing at 56 ℃ for 30s and extension at 72℃ for 1 cycle. A total of 25 cycles were performed for sequencing PCR amplification. The amplified products were purified by ethanol precipitation method. | Other | donor/acceptor expression group |
| CYP3A5*3*32ml of venous blood was drawn and placed in an EDTA anticoagulant tube. Peripheral blood genomic DNA was extracted according to the instructions of the DNA extraction kit.The reaction system was prepared by polymerase chain reaction (PCR) according to the instructions of PCR amplification system.After 25g/L agarose gel electrophoresis, the bands of amplified products were observed under UV lamp. The PCR products were purified by enzymolysis. The purified product was prepared according to sequencing PCR amplification system. After 1min predenaturation at 96℃, denaturation at 96℃ for 30s, annealing at 56 ℃ for 30s and extension at 72℃ for 1 cycle. A total of 25 cycles were performed for sequencing PCR amplification. The amplified products were purified by ethanol precipitation method. | Other | donor/acceptor non-expression group |
Primary outcome
Fk506
Time frame: 1-28 days postoperatively
Tacrolimus concentration
Scr
Time frame: 1-28 days postoperatively
Reflects indicators of kidney function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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.
Liziqiang Liziqiang, Doctor study director
Party
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 Complete and Accurate Statistical Data of 60 Patients and CYP3A5*3 Genotypes of 60 Donors and Recipients Were Analyzed Accurately, run by Ziqiang Li 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 3 inclusion and 5 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 20 Mar 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fk506 (time frame: 1-28 days postoperatively). 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 20 Mar 2024.