Tokyo, June 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061789) titled 'Long-term retrospective effects of add-on finerenone therapy in patients with diabetic kidney disease' on June 5.
Study Type:
Observational
Primary Sponsor:
Institute - Minami Osaka hospital
Condition:
Condition - Type 2 diabetes mellitus with diabetic kidney disease (DKD)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the 2-year eGFR slope following add-on finerenone therapy in patients with type 2 diabetes mellitus and diabetic kidney disease (DKD) receiving SGLT2 inhibitor treatment, and to assess its impact on the rate of renal function decline. Changes in albuminuria and safety outcomes will also be evaluated.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients diagnosed with type 2 diabetes mellitus
Patients with diabetic kidney disease (DKD)
Patients newly initiated on finerenone while receiving SGLT2 inhibitor therapy
Availability of eGFR data for at least 12 months before finerenone initiation
Availability of follow-up data for at least 24 months after finerenone initiation
Key exclusion criteria - Patients receiving dialysis therapy
Patients with a history of kidney transplantation
Patients with acute kidney injury
Patients with missing data required for analysis
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 01 Day
Anticipated trial start date - 2026 Year 06 Month 04 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070710
Disclaimer: Curated by HT Syndication.
