Effect of Azole/Echinocandin Use on Tacrolimus Pharmacokinetics
NCT ID: NCT06044558
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
507 participants
OBSERVATIONAL
2022-09-01
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Combined with voriconazole group
Methylprednisolone sodium succinate was administered intravenously the day after transplantation at an initial dose of 500 mg/day, with the dose being tapered evenly to 40 mg/day during the first week. During the second week, methylprednisolone tablets were administered continuously at a dose of 40 mg/day, after which the dose was tapered to 16 mg/day as a maintenance dose. Immunosuppression was maintained with oral mycophenolate sodium 720 mg twice daily. For renal transplant patients, the initial oral tacrolimus dose should be 0.15 - 0.30 mg/kg per day divided into morning and evening doses. The starting dose of voriconazole should be 400 mg twice a day, which should be changed to 200 mg twice a day from the next day as a maintenance dose.
Combined with voriconazole
Renal transplant patients taking tacrolimus-based triple immunotherapy and voriconazole drug combination.
Combined with caspofungin group
Methylprednisolone sodium succinate was administered intravenously the day after transplantation at an initial dose of 500 mg/day, with the dose being tapered evenly to 40 mg/day during the first week. During the second week, methylprednisolone tablets were administered continuously at a dose of 40 mg/day, after which the dose was tapered to 16 mg/day as a maintenance dose. Immunosuppression was maintained with oral mycophenolate sodium 720 mg twice daily. For renal transplant patients, the initial oral tacrolimus dose should be 0.15 - 0.30 mg/kg per day divided into morning and evening doses. The dosage of caspofungin was 70 mg intravenous injection once on the first day after surgery and 50 mg intravenous injection once a day starting from the second day.
Combined with caspofungin
Renal transplant patients taking a combination of tacrolimus-based triple immunotherapy and caspofungin drugs.
Tacrolimus-alone treatment group
Methylprednisolone sodium succinate was administered intravenously the day after transplantation at an initial dose of 500 mg/day, with the dose being tapered evenly to 40 mg/day during the first week. During the second week, methylprednisolone tablets were administered continuously at a dose of 40 mg/day, after which the dose was tapered to 16 mg/day as a maintenance dose. Immunosuppression was maintained with oral mycophenolate sodium 720 mg twice daily. For renal transplant patients, the initial oral tacrolimus dose should be 0.15 - 0.30 mg/kg per day divided into morning and evening doses.
Tacrolimus-alone treatment
Renal transplant patients treated with tacrolimus-based triple immunotherapy alone
Interventions
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Combined with voriconazole
Renal transplant patients taking tacrolimus-based triple immunotherapy and voriconazole drug combination.
Combined with caspofungin
Renal transplant patients taking a combination of tacrolimus-based triple immunotherapy and caspofungin drugs.
Tacrolimus-alone treatment
Renal transplant patients treated with tacrolimus-based triple immunotherapy alone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Renal transplant recipients taking a tacrolimus-based triple immunosuppressive regimen (tacrolimus + sodium mescaline enteric-coated tablets + glucocorticoids) postoperatively;
3. Age ≥ 18 years.
Exclusion Criteria
2. Multi-organ combined transplantation and secondary transplantation;
3. Postoperative simultaneous joint application of other drugs that affect the blood concentration of tacrolimus or voriconazole or caspofungin (e.g. pentoxifylline capsules, rifampicin, etc.);
4. Severe impairment of liver function or severe gastrointestinal diseases, gastrointestinal resection surgery, malabsorption syndrome;
5. Pregnant and lactating women;
6. Recipients with significant rejection of the transplanted organ or death due to other reasons within 1\~2 months after surgery;
7. Poor compliance and accuracy of results (e.g., irregular blood collection times).
18 Years
80 Years
ALL
No
Sponsors
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LI YAN
OTHER
Responsible Party
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LI YAN
director
Locations
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Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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QFS-LY-2023-TAC-001
Identifier Type: -
Identifier Source: org_study_id
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