SGLT2 Inhibitors and Renal Anemia in Japan: RWD

NCT07063316 | Active Not Recruiting

• 1 other identifier: 1245-0387
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of the study are:

1. 1.To evaluate the association between Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitor use and the occurrence of anemia in patients with chronic kidney disease (CKD) using a nested case-control design with incidence density sampling.
2. 2.To evaluate anemia-related outcomes using a nested case-control-based analytical framework, including assessment of within-subject changes in anemia-related treatments and healthcare costs by comparing the period after study entry with the period after the index date (for cases) or matched reference date (for controls), and comparison according to SGLT2 inhibitor use:

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Time to the first occurrence of anemia (composite anemia outcomes)

  The composite of anemia outcomes is defined as any of the following: * Hb \< 13.0 g/dL for men or \< 12.0 g/dL for women * Clinical diagnosis of anemia using ICD-10 diagnosis codes * Initiation of anemia treatment (Erythropoiesis-Stimulating Agents (ESAs), Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH) inhibitors, iron preparations, or red blood cell (RBC) transfusion

  From the study cohort entry date to first event occurrence (for cases) or matched reference date (for controls), up to 13 years

Secondary Outcomes (3)

• Number of administered doses of ESA, HIF-PH inhibitors, iron preparations, and RBC transfusions

  From the study cohort entry date to the index date (for cases) or matched reference date (for controls), up to 24 months

• Anemia-related healthcare costs

  From the study cohort entry date to the index date (for cases) or matched reference date (for controls), up to 24 months

• Frequency of administration of ESA, HIF-PH inhibitors, iron preparations, and RBC transfusions

  From the study cohort entry date to the index date (for cases) or matched reference date (for controls), up to 24 months

Study Arms (2)

SGLT2 inhibitor users

Drug: SGLT2 inhibitor

SGLT2 inhibitor non-users

Interventions

SGLT2 inhibitor DRUG

SGLT2 inhibitor

SGLT2 inhibitor users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic kidney disease patients registered in the Medical Data Vision (MDV) database in Japan.

You may qualify if:

• Have two consecutive estimated glomerular filtration rate (eGFR) measurements \< 60 mL/min/1.73 m2 at least 92 days apart between April 17, 2014 and October 31, 2022.
• Aged 18 years or older at the study cohort entry date.
• Have at least one haemoglobin (Hb) measurement at the study cohort entry date or within 183 days before the study cohort entry date.

You may not qualify if:

• Have less than 183 days of record history before the study cohort entry date.
• Have any prescription record for an SGLT2 inhibitor at the study cohort entry date or within 183 days before the study cohort entry date
• Have evidence of anemia at the study cohort entry date or within 183 days before the study cohort entry date.
• Hemoglobin (Hb) \< 13.0 g/dL for men or \< 12.0 g/dL for women
• Hematocrit (Ht) \< 39% for men or \< 36% for women
• Have a history of prescribed anemia-related medications and treatments at the study cohort entry date or within 183 days before the study cohort entry date.
• Have evidence of anemia-causing conditions other than chronic kidney disease (CKD) at the study cohort entry date or within 183 days before the study cohort entry date.
• Confirm at least one instance of hemodialysis, peritoneal dialysis, or kidney transplantation at the study cohort entry date or within 183 days before the study cohort entry date.

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Nippon Boehringer Ingelheim Co ., Ltd.

Tokyo, 1416017, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 14, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)