SGLT2 Inhibitors and Renal Anemia in Japan: RWD
Launched by BOEHRINGER INGELHEIM · Jul 11, 2025
Trial Information
Current as of July 24, 2025
Not yet recruiting
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.
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tokyo, , Japan
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported