SGLT2 Inhibitors and Renal Anemia in Japan: RWD

NCT ID: NCT07063316

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-23

Study Completion Date

2026-02-28

Brief Summary

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The objectives of the study are:

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. To compare the following outcomes from the index date to 731 days (24 months) or the end date of each individual's follow-up:

A) Longitudinal changes in laboratory values between SGLT2 inhibitor users and non-users in patients with CKD.

B) Prescription patterns and treatment regimens for anemia between SGLT2 inhibitor users and non-users in patients with CKD, including analysis of medication types, dosing strategies, and duration of treatments.

C) Anemia-related healthcare costs between SGLT2 inhibitor users and non-users.

Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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SGLT2 inhibitor users

SGLT2 inhibitor

Intervention Type DRUG

SGLT2 inhibitor

SGLT2 inhibitor non-users

No interventions assigned to this group

Interventions

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SGLT2 inhibitor

SGLT2 inhibitor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Aged 18 years or older at the index date.

Exclusion Criteria

1. Have less than 183 days of record history before the index date.
2. Have a any prescription record for an SGLT2 inhibitor at the index date or within 183 days before the index date
3. 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.
4. Have evidence of anemia-causing conditions other than chronic kidney disease (CKD) at the index date or within 183 days before the index date.
5. Confirm at least one instance of hemodialysis, peritoneal dialysis, or kidney transplantation at the index date or within 183 days before the index date.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nippon Boehringer Ingelheim Co ., Ltd.

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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1245-0387

Identifier Type: -

Identifier Source: org_study_id

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