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Active, not recruitingNCT07063316Updated Sep 16, 2026

SGLT2 Inhibitors and Renal Anemia in Japan: RWD

An observational study in Chronic Kidney Disease, sponsored by Boehringer Ingelheim. Active, not recruiting at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
15,000
Ages
18 Years and older
Sex
All
01

Study 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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Conditions studied

  • Chronic Kidney Disease
03

In context

Renal Insufficiency, Chronic

3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.

This study's planned enrollment of 15,000 is above the median of 200 across 867 observational studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
15,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • SGLT2 inhibitor users

    Drug: SGLT2 inhibitor

  • SGLT2 inhibitor non-users

Interventions

  • DrugSGLT2 inhibitor

    SGLT2 inhibitor

06

What researchers measure

Primary outcomes

  1. 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

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

Secondary outcomes

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

    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

    Time frame: 1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls)

  2. Anemia-related healthcare costs

    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

    Time frame: 1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls)

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

    -outcome evaluated as within-subject changes between pre- and post-index/reference periods

    Time frame: 1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls)

07

Study locations

1 site
  • Nippon Boehringer Ingelheim Co ., Ltd.
    Tokyo, 1416017, Japan
08

References and documents

Related links

Individual participant data

Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07063316
Lead sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
Responsible party
Sponsor
First posted
Jul 14, 2025
Start date
Jul 23, 2025
Primary completion
Dec 25, 2026 (estimated)
Completion
Dec 25, 2026 (estimated)
Last update
Sep 16, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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