SGLT2 Inhibitors and Renal Anemia in Japan: RWD

NCT07063316 — Active not recruiting, 15000 participants, Boehringer Ingelheim

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Effect of SGLT2 Inhibitors on Renal Anemia and Its Management in Patients With CKD in Japan

Registry	NCT07063316
Status	Active not recruiting
Study type	Observational
Enrollment	15000 (Estimated)
Sponsor	Boehringer Ingelheim (Industry); collaborators: Eli Lilly and Company
Conditions	Chronic Kidney Disease
Interventions	SGLT2 inhibitor (Drug)
Dates	start 2025-07-23, primary completion 2026-12-25 (estimated), completion 2026-12-25 (estimated), first posted 2025-07-14, last updated 2026-09-16
Locations	1 site in Japan

-Summary

The objectives of the study are:

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. 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:

A) Prescription patterns and treatment regimens for anemia, including analysis of medication types, dosing strategies, and duration of treatments B) Anemia-related healthcare costs C) Change in laboratory values

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+Arms and interventions

Arm	Type	Interventions	Description
SGLT2 inhibitor users		Drug: SGLT2 inhibitor
SGLT2 inhibitor non-users

SGLT2 inhibitor (Drug): SGLT2 inhibitor

+Outcome measures

Primary outcomes

First occurrence of anemia (composite anemia outcomes) [From the study cohort entry date to first event occurrence (for cases) or matched reference date (for controls), up to 13 years]: 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

Secondary outcomes

Number of administered doses of ESA, HIF-PH inhibitors, iron preparations, and RBC transfusions [1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls)]: Erythropoiesis-Stimulating Agents (ESAs) Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH) Red blood cell (RBC) transfusions -outcome evaluated as within-subject changes between pre- and post-index/reference periods
Anemia-related healthcare costs [1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls)]: Anemia-related medical costs are defined as the sum of direct medical costs associated with the treatment of anemia. These costs will include medication costs and costs related to RBC transfusion. -outcome evaluated as within-subject changes between pre- and post-index/reference periods
Frequency of administration of ESA, HIF-PH inhibitors, iron preparations, and RBC transfusions [1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls)]: -outcome evaluated as within-subject changes between pre- and post-index/reference periods

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. 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.
2. Aged 18 years or older at the study cohort entry date.
3. Have at least one haemoglobin (Hb) measurement at the study cohort entry date or within 183 days before the study cohort entry date.

Exclusion Criteria:

1. Have less than 183 days of record history before the study cohort entry date.
2. Have any prescription record for an SGLT2 inhibitor at the study cohort entry date or within 183 days before the study cohort entry date
3. 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.
4. 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.
5. 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.

+Locations (1)

Facility	City	Country	Status
Nippon Boehringer Ingelheim Co ., Ltd.	Tokyo	Japan