Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
15000 participants
OBSERVATIONAL
2025-07-23
2026-02-28
Brief Summary
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1. To compare the risk and timing of anemia onset between Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitor users and non-users in patients with chronic kidney disease (CKD) from the index date to first event occurrence or the end date of each individual's follow-up.
2. To compare the following outcomes from the index date to 731 days (24 months) or the end date of each individual's follow-up:
A) Longitudinal changes in laboratory values between SGLT2 inhibitor users and non-users in patients with CKD.
B) Prescription patterns and treatment regimens for anemia between SGLT2 inhibitor users and non-users in patients with CKD, including analysis of medication types, dosing strategies, and duration of treatments.
C) Anemia-related healthcare costs between SGLT2 inhibitor users and non-users.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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SGLT2 inhibitor users
SGLT2 inhibitor
SGLT2 inhibitor
SGLT2 inhibitor non-users
No interventions assigned to this group
Interventions
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SGLT2 inhibitor
SGLT2 inhibitor
Eligibility Criteria
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Inclusion Criteria
2. Aged 18 years or older at the index date.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Nippon Boehringer Ingelheim Co ., Ltd.
Tokyo, , Japan
Countries
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Related Links
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Related Info
Other Identifiers
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1245-0387
Identifier Type: -
Identifier Source: org_study_id
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