UMIN-ICDS Clinical Trial

Public title

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)

Acronym

Improving CKD Diagnosis and Treatment Rates Through Support Programs in Primary Care Settings.

Scientific Title

Improving CKD Diagnosis and Treatment Rates Through Support Programs in Primary Care Settings.

Scientific Title:Acronym

CKD Support Program Implementation Study

Region

Japan

Condition

Chronic kidney disease (CKD)

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

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

Basic objectives -Others

To evaluate changes in the prescription rate of SGLT2 inhibitors among primary care physicians (PCPs).

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

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.

Key secondary outcomes

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

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 sample size

20

Name of lead principal investigator

1st name	Kazuhiro
Middle name
Last name	Yoneda

Organization

Nippon Boehringer Ingelheim Co., Ltd.

Division name

Clinical Development and Medical Affairs

Zip code

141-6017

Address

ThinkPark Tower, 2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan

TEL

03-6417-2200

Email

kazuhiro.yoneda@boehringer-ingelheim.com

Name of contact person

1st name	Yuta
Middle name
Last name	Asanuma

Organization

Mebix, Inc.

Division name

Research Promotion Division

Zip code

105-0001

Address

10th Floor, Toranomon 33 Mori Building, 3-8-21 Toranomon, Minato-ku, Tokyo, Japan

TEL

03-4362-4504

Homepage URL

Email

Implementation_Study_Support@mebix.co.jp

Institute

Nippon Boehringer Ingelheim Co., Ltd.

Institute

Department

Personal name

Organization

Nippon Boehringer Ingelheim Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Nihonbashi Sakura Clinic, Ouryokukai Medical Corporation

Address

5th Floor, Inamura Building, 1-9-2 Nihonbashi Kayabacho, Chuo-ku, Tokyo

Tel

03-6661-9061

Email

c-irb_ug@neues.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

06

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

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

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is an implementation science study aimed at evaluating the impact of the clinical implementation of a multichannel educational support program on clinical practice behavior in the primary care setting in Japan.
Using a database, changes in clinical indicators before and after the introduction of the support program will be assessed.

Registered date

2026

Year

06

Month

14

Day

Last modified on

2026

Year

06

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070827