Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060242) titled 'Effects of Additional Spironolactone on Persistent Proteinuria After SGLT2 Inhibitor Therapy in Patients with Diabetic Kidney Disease' on March 1.
Study Type:
Observational
Primary Sponsor:
Institute - Jinnouchi Hospital
Condition:
Condition - Type-2 diabetes
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - spironolactone therapy-induced changes in urinary protein-to-creatinine ratio (UPCR) levels
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - stable adult T2DM patients demonstrated persistent proteinuria (UPCR; A2 to A3; >0.15 g/gCre) despite more than 6 months of SGLT2i therapy (dapagliflozin; 10 mg/day) at the outpatient's department in Jinnouchi Hospital between January 2019 and July 2022 and initiated additional spironolactone therapy (initial dose; 12.5 mg/day). Patients were included if levels of proteinuria and eGFR measurements were performed both before and after the initiation of spironolactone and follow-up periods were 12 months.
Key exclusion criteria - Patients with hyperkalemia (K>5.5), cancer, severe infection, recent cardiovascular events, heart failure (New York Heart Association class III or higher), advanced chronic kidney disease (eGFR<15 mL/min/1.73 m2), advanced hepatic diseases, or concomitant use of eplerenone were excluded.
Target Size - 29
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2023 Year 11 Month 06 Day
Date of IRB - 2023 Year 11 Month 06 Day
Anticipated trial start date - 2023 Year 11 Month 07 Day
Last follow-up date - 2025 Year 12 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068891
Disclaimer: Curated by HT Syndication.
