Tokyo, June 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061898) titled 'Improving CKD Diagnosis and Treatment Rates Through Support Programs in Primary Care Settings: A Scientific Approach to Investigating a Multi-Channel Support Program to Improve CKD Diagnosis and Management in Primary Care (Phase 2)' on June 15.

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 - Phase2 implements a multi-channel support program to evaluate the implementation of guideline-directed SGLT2 inhibitor therapy for CKD in primary care settings and its impact on clinical outcomes. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - The study population of this study consists of primary care physicians (clinics) selected for the support program and the patients included in the analysis.

Inclusion criteria (clinic): - Clinics registered in the JAMDAS database - Clinics in which both the facility-level CKD diagnosis rate and the prescription rate of SGLT2 inhibitors among eligible patients are below average during the period from March 1, 2025 to February 28, 2026 - Clinics treating at least 80 eligible patients - Clinics with at least approximately 2 years and 4 months of data history prior to October 1, 2026 - Clinics with records of eGFR testing - Clinics with records of urine testing - Clinics that list among their departments general internal medicine, cardiology, gastroenterology, respiratory medicine, diabetology/endocrinology/metabolism, rheumatology/collagen diseases, or allergy

Inclusion criteria (patients): - Patients aged 18 years or older - Patients who meet at least one of the following renal function criteria: - A recorded diagnosis of CKD - A recorded eGFR of less than 60 mL/min/1.73 m2 - Presence of proteinuria (category A2 or higher) - Patients who meet at least one of the following comorbidity criteria: - A recorded diagnosis of diabetes mellitus (DM) - No diagnosis of DM but presence of proteinuria (category A2 or higher) - Patients with a recorded eGFR of 20 mL/min/1.73 m2 or higher

Among the above criteria, age (18 years or older) is assessed at the start date of each observation period. Renal function, comorbidities, and eGFR criteria are evaluated based on the most recent data within the look-back period. Key exclusion criteria - Exclusion criteria (clinic): - Clinics with two or more physicians - Clinics with a board-certified nephrologist of the Japanese Society of Nephrology or a dialysis specialist - Clinics that include nephrology in their listed departments

Exclusion criteria (patients): - Patients with a recorded eGFR of less than 20 mL/min/1.73 m2 - Patients with end-stage renal disease, including those who have undergone kidney transplantation or are receiving maintenance hemodialysis or peritoneal dialysis - Patients diagnosed with type 1 diabetes mellitus - Patients who are pregnant or have a recorded pregnancy Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 08 Day Date of IRB - 2026 Year 05 Month 20 Day Anticipated trial start date - 2026 Year 06 Month 15 Day Last follow-up date - 2028 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070827

Disclaimer: Curated by HT Syndication.