Tokyo, July 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062116) titled 'Estimating Trial-Eligible CKD Populations for Major Kidney Outcome Trials and SGLT2 Inhibitor Benefits in Japan: A Descriptive Analysis and Projection of SGLT2 Inhibitor Prescription and Potential Reductions in ESKD and Cardiovascular Events' on July 2.
Study Type:
Observational
Primary Sponsor:
Institute - Nippon Boehringer Ingelheim Co., Ltd.
Condition:
Condition - Chronic Kidney Disease (CKD)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To estimate the number of CKD patients across Japan meeting the eligibility criteria of major sodium-glucose cotransporter 2 inhibitor (SGLT2i) clinical trials for kidney outcome, and the number of those prescribed SGLT2i.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
1.Have at least one instance between January 1 and December 31, 2024, in which both estimated glomerular filtration rate (eGFR) and urinary protein test results are recorded on the same day.
2.Have at least three eGFR measurements, including one on the index date during baseline period, and have the earliest eGFR measurement and the index date separated by at least 2 years.
3.Have been continuously enrolled in the JMDC database throughout the 3-year baseline period.
Key exclusion criteria -
No exclusion criteria were defined.
Target Size - 540000
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 10 Day
Date of IRB - 2026 Year 06 Month 29 Day
Anticipated trial start date - 2026 Year 06 Month 29 Day
Last follow-up date - 2026 Year 06 Month 29 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071056
Disclaimer: Curated by HT Syndication.
