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NCT Number: NCT07063316

SGLT2 Inhibitors and Renal Anemia in Japan: RWD

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nippon Boehringer Ingelheim Co ., Ltd.

Tokyo, 1416017, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SGLT2 inhibitor

Drug

SGLT2 inhibitor

Primary outcomes

  1. Time to the 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

Secondary outcomes

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

    Time frame: From the study cohort entry date to the index date (for cases) or matched reference date (for controls), up to 24 months

    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

  2. Anemia-related healthcare costs

    Time frame: From the study cohort entry date to the index date (for cases) or matched reference date (for controls), up to 24 months

    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

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

    Time frame: From the study cohort entry date to the index date (for cases) or matched reference date (for controls), up to 24 months

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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