Chronic kidney disease (CKD)
Conditions
Interventions
None listed
Sponsors
Nippon Boehringer Ingelheim Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the change in the prescription rate of SGLT2 inhibitors between the pre-support program introduction observation period and the post-support program introduction observation period. The prescription rate is defined as the proportion of patients who were prescribed an SGLT2 inhibitor at least once during each observation period among all patients who met the eligibility criteria at the start of the respective observation period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary outcomes are the changes between the pre-support program introduction observation period and the post-support program introduction observation period in CKD screening rate, CKD diagnosis rate, eGFR, eGFR slope, and proteinuria status. The CKD screening rate is assessed as the proportion of eligible patients with records of both blood testing (eGFR or serum creatinine) and urine testing. The CKD diagnosis rate is assessed as the proportion of eligible patients with a recorded CKD diagnosis. eGFR is evaluated using the last valid measurement in each observation period, eGFR slope is estimated from serial eGFR measurements within each period, and proteinuria status is assessed using UACR, UPCR, or qualitative urine protein test results. | — |
Countries
Japan
Contacts
Public ContactYuta Asanuma
Mebix, Inc. Research Promotion Division
Outcome results
None listed