SGLT2 Inhibitors and Renal Anemia in Japan: RWD

An observational study of Chronic Kidney Disease, run by Boehringer Ingelheim at 1 site in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease
What is being tested?: SGLT2 inhibitor
How many people: 15,000 participants
Where: 1 siteJapan
Study dates: 23 Jul 2025to 25 Dec 2026
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Nippon Boehringer Ingelheim Co ., Ltd.
Tokyo, 1416017

Other trials in Japan

About this study

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

The objectives of the study are:

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.
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:
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

Conditions: Chronic Kidney Disease
Being tested: SGLT2 inhibitor
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SGLT2 inhibitorDrug
SGLT2 inhibitor

Study groups in NCT07063316
Study group	Role	What they receive
SGLT2 inhibitor users		Not described Receives: Drug: SGLT2 inhibitor
SGLT2 inhibitor non-users		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 202525 Dec 2026

First posted14 Jul 2025
Study start23 Jul 2025
Primary completion25 Dec 2026 (estimated)
Study completion25 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 15,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07063316
Sponsor's protocol ID: 1245-0387
Status last verified: Sep 2026
First submitted: 24 Jun 2025
Last updated: 16 Sep 2026
Results posted: No
Data monitoring committee: No
Individual data sharing: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of SGLT2 Inhibitors on Renal Anemia and Its Management in Patients With CKD in Japan
ClinicalTrials.gov ID: NCT07063316
Acronym / sponsor ID: 1245-0387
Conditions: Chronic Kidney Disease
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 15,000 participants (estimated)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 23 Jul 2025 (actual)
Primary completion: 25 Dec 2026 (estimated)
Study completion: 25 Dec 2026 (estimated)
First posted: 14 Jul 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objectives of the study are:

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.
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:
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

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
SGLT2 inhibitor users	–	Drug: SGLT2 inhibitor
SGLT2 inhibitor non-users	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Chronic kidney disease patients registered in the Medical Data Vision (MDV) database in Japan.

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (8 listed)

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.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SGLT2 inhibitorSGLT2 inhibitor	Drug	SGLT2 inhibitor users

Primary outcome

First occurrence of anemia (composite anemia outcomes)
Time frame: 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

3 secondary outcomes

Number of administered doses of ESA, HIF-PH inhibitors, iron preparations, and RBC transfusions
Time frame: 1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls)
Anemia-related healthcare costs
Time frame: 1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls)
Frequency of administration of ESA, HIF-PH inhibitors, iron preparations, and RBC transfusions
Time frame: 1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: 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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RecruitingPhase 3
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Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Disease, run by Boehringer Ingelheim at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First occurrence of anemia (composite anemia outcomes) (time frame: From the study cohort entry date to first event occurrence (for cases) or matched reference date (for controls), up to 13 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07063316.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.