NCT07063316Active, not recruiting
SGLT2 Inhibitors and Renal Anemia in Japan: RWD
Effect of SGLT2 Inhibitors on Renal Anemia and Its Management in Patients With CKD in Japan
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 15000 (estimated)
- First submitted
- 24 Jun 2025
- Start date
- 23 Jul 2025
- Primary completion date
- 25 Dec 2026
- Lead sponsor
- Boehringer Ingelheim
- Diseases
- Chronic kidney disease
- NCT number
- NCT07063316
What you commit to
- Study type: Observational
- Planned participants: 15000
- From 23 Jul 2025 to the primary completion date, 25 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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-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.
Lab values
- 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.
Other
- Have less than 183 days of record history before the study cohort entry date.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nippon Boehringer Ingelheim Co., Ltd. Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.