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SGLT2 Inhibitors and Renal Anemia in Japan: RWD

StatusActive, Not Recruiting
PhaseNot specified
Started2025-07-23
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Boehringer Ingelheim

Amendment history

2026-09-17
Primary endpoint(s) modified1 entry, revised
WasTime to the first occurrence of anemia (composite anemia outcomes)
NowFirst occurrence of anemia (composite anemia outcomes)
2026-05-04
Study Status, Study Description, Study Design, Outcome Measures, Eligibility v3
Primary completion pushed: 2026-09-30 → 2026-12-25
Completion pushed: 2026-09-30 → 2026-12-25
Eligibility criteria+286 characters
[...] urements < 60 mL/min/1.73 m2 at least 92 days apart between OctoberApril 117, 20132014 and October 31, 2022. Aged 18 years or older at the indexstudy 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 indexstudy cohort entry date. Have a any prescription record for an SGLT2 inhibitor at the indexstudy cohort entry date or within 183 days before the indexstudy cohort entry date Have evidence of anemia at the indexstudy coho [...] [...]
Secondary endpointsdetails revised at 3 of 3 entries
2026-03-03
Study Status v2
Primary completion date2026-02-28→2026-09-30
Completion date2026-02-28→2026-09-30
2025-07-23
Not Yet Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Active, Not Recruiting
Primary completion date2025-12-31→2026-02-28
Completion date2025-12-31→2026-02-28
Start dateestimated 2025-07-08→confirmed 2025-07-23
2025-07-11
Original filing
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
Trial Details
NCT Number NCT07063316
Lead Sponsor Boehringer Ingelheim
Collaborators: Eli Lilly and Company
Conditions Chronic Kidney Disease
Enrollment 15,000 participants
Start Date 2025-07-23
Primary Completion 2026-12-25 (estimated)
Study Completion 2026-12-25 (estimated)
Updated on ClinicalTrials.gov 2026-09-16