Tokyo, May 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061408) titled 'A Prospective Study Investigating Predictability and Discrepancies in Initial Tacrolimus Dosing Using Genetic Information' on May 1.
Study Type:
Observational
Primary Sponsor:
Institute - Shonan Kamakura General Hospital, Tokushukai Medical Corporation
Condition:
Condition - Immunosuppressive therapy (tacrolimus dosing) in kidney transplant recipients
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - The objective of this study is to characterize discrepancies between predicted and observed tacrolimus concentrations in a CYP3A5 genotype-based initial dosing model and to identify their clinical patterns.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients undergoing kidney transplantation who initiate tacrolimus-based immunosuppressive therapy and provide informed consent for participation.
Key exclusion criteria - Patients in whom tacrolimus trough concentrations cannot be measured on the morning of day 4 before the fourth dose, or those deemed inappropriate for inclusion by the investigator.
Target Size - 74
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 16 Day
Anticipated trial start date - 2026 Year 05 Month 01 Day
Last follow-up date - 2028 Year 05 Month 15 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070253
Disclaimer: Curated by HT Syndication.
