Active — Not RecruitingNot Applicable

SGLT2 Inhibitors and Renal Anemia in Japan: RWD

Japan15,000 participantsStarted 2025-07-23

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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.
✕. 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.

What they're measuring

Time to the first occurrence of anemia (composite anemia outcomes)

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

Trial details

NCT IDNCT07063316

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12-25

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