Sponsor study identifier
observational
507
1 country
1
Study Start
September 1, 2022
Actual (reported)Primary Completion
January 1, 2023
Actual (reported)Study Completion
June 1, 2023
Actual (reported)The purpose of this observational study is to analyze the extent and characteristics of drug interactions (focusing on azole antifungals and echinocandins) and genetic polymorphisms on tacrolimus blood concentrations in renal transplant recipients in order to provide a reference for the appropriate adjustment of tacrolimus dosing regimen to reduce the incidence of adverse drug reactions and rejection, and to improve the survival of transplanted kidneys.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2023
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2022
Actual (reported)January 1, 2023
Actual (reported)June 1, 2023
Actual (reported)August 28, 2023
Actual (reported)September 21, 2023
Actual (reported)The C0/D values of tacrolimus
Body weight is in kilograms, D values are in mg/d, and the combination of body weight and D is the body weight-corrected D value in mg/kg/d, with a range of 0.15-0.30 mg/kg/d. The C0 for tacrolimus is in ng/ml, with a range of 5-15 ng/ml, and the combination of the C0 and body weight-corrected D values is the C0/D value, reported as (ng/ml)/(mg /kg/d) is reported.
2015.01.01-2023.04.01
The D values of tacrolimus
2015.01.01-2023.04.01
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.
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.
Renal transplant patients taking tacrolimus-based triple immunotherapy and voriconazole drug combination.
Renal transplant patients taking a combination of tacrolimus-based triple immunotherapy and caspofungin drugs.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment programme
Combined with voriconazole
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordTreatment programme
Combined with caspofungin
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordThe study included patients who underwent renal transplantation at our hospital between 01.01.2015 and 04.01.2023 and were divided into the co-voriconazole group, co-carbophenazole group and tacrolimus alone group according to co-administration.
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
507 participants (actual enrollment reported by the registry).
First Submitted
August 28, 2023
First Posted
September 21, 2023
Study Start
September 1, 2022
Actual (reported)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.
Renal transplant patients treated with tacrolimus-based triple immunotherapy alone
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Primary Completion
January 1, 2023
Actual (reported)Study Completion
June 1, 2023
Actual (reported)Last Updated
September 28, 2023
Record last verified: 2023-09
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Source: ClinicalTrials.gov.
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