Clinical Trial: Subanalysis of RESTORE-nephropathy study (the research to explore the effects of a SGLT2 inhibitor, tofogliflozin, on renal protection estimated by first administration and readministration in patients with stage 2-3 diabetic nephropathy) (Japan)

Tokyo, May 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061329) titled 'Investigation of factors associated with changes in urinary albumin when SGLT2 inhibitor, tofogliflozin, is initially administered or readministered to type 2 diabetic patients with stage 2-3 diabetic nephropathy' on May 1.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - Japan society for patient reported outcome

Condition: Condition - Stage 2-3 diabetic nephropathy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effects of initially administered and readministered sodium glucose cotransporter-2 (SGLT2) inhibitor, tofogliflozin, on urinary albumin in type 2 diabetic patients with stage 2-3 diabetic nephropathy. By using the dataset of RESTORE-nephropathy study, we investigate the relationship between the changes in urinary albumin and 2 fractions of urinary metanephrine (metanephrine and normetanephrine), which are the indicators of sympathetic nerve activity, caused by tofogliflozin administration. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - Individuals with type 2 diabetes mellitus and stage 2 or 3 diabetic nephropathy Key exclusion criteria - Individuals with type 1 diabetes or secondary diabetes, individuals with a history of SGLT2 inhibitor use, individuals who started to use or changed the dose of angiotensin-converting enzyme inhibitors or angitotensin receptor blockers within 3 months before giving their informed consent. Target Size - 47

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 05 Day Date of IRB - 2026 Year 03 Month 23 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2026 Year 10 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070157

Disclaimer: Curated by HT Syndication.