SGLT2 Inhibitors and Renal Anemia in Japan: RWD

Launched by BOEHRINGER INGELHEIM · Jul 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a type of medication called SGLT2 inhibitors affects anemia (a condition where the blood has fewer healthy red blood cells) in people with chronic kidney disease (CKD). The researchers want to find out if people taking these medications are less likely to develop anemia, how their blood test results change over time, what kinds of anemia treatments they might need, and how much their anemia-related healthcare costs. This study will look at real-world data from patients in Japan over about two years.

To be part of the study, patients need to be adults with CKD, shown by specific blood tests that measure kidney function, and must not already have anemia or be using SGLT2 inhibitors when the study begins. Participants won’t be receiving new treatments as part of the trial; instead, the study will review their medical records to compare those who use SGLT2 inhibitors with those who do not. This helps researchers understand how these medications might help prevent or delay anemia in people with CKD. The study is not yet recruiting participants but will include adults of all genders who meet the criteria.

Gender

ALL

Eligibility criteria

• 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.