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 compare the risk and timing of anemia onset between Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitor users and non-users in patients with chronic kidney disease (CKD) from the index date to first event occurrence or the end date of each individual's follow-up.
2. 2.To compare the following outcomes from the index date to 731 days (24 months) or the end date of each individual's follow-up:

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 index date to first event occurrence or the end date of each individual's follow-up, up to 13 years

Secondary Outcomes (3)

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

  Up to 24 months

• Anemia-related healthcare costs

  Up to 24 months

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

  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 October 1, 2013 and October 31, 2022.
• Aged 18 years or older at the index date.

You may not qualify if:

• Have less than 183 days of record history before the index date.
• Have a any prescription record for an SGLT2 inhibitor at the index date or within 183 days before the index date
• Have evidence of anemia at the index date or within 183 days before the index 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 index date or within 183 days before the index date.
• Have evidence of anemia-causing conditions other than chronic kidney disease (CKD) at the index date or within 183 days before the index date.
• Confirm at least one instance of hemodialysis, peritoneal dialysis, or kidney transplantation at the index date or within 183 days before the index 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: COHORT
• 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): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)