SGLT2 Inhibitors and Renal Anemia in Japan: RWD
- Conditions
- Chronic Kidney Disease
- Interventions
- Drug: SGLT2 inhibitor
- Registration Number
- NCT07063316
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objectives of the study are:
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 15000
- 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.
- Aged 18 years or older at the index date.
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Have less than 183 days of record history before the index date.
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Have a any prescription record for an SGLT2 inhibitor at the index date or within 183 days before the index date
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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.
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Have evidence of anemia-causing conditions other than chronic kidney disease (CKD) at the index date or within 183 days before the index date.
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Confirm at least one instance of hemodialysis, peritoneal dialysis, or kidney transplantation at the index date or within 183 days before the index date.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SGLT2 inhibitor users SGLT2 inhibitor -
- Primary Outcome Measures
Name Time Method Time to the first occurrence of anemia (composite anemia outcomes) From the index date to first event occurrence or the end date of each individual's follow-up, up to 13 years The composite of anemia outcomes is defined as any of the following:
* Hb \< 13.0 g/dL for men or \< 12.0 g/dL for women
* Clinical diagnosis of anemia using ICD-10 diagnosis codes
* Initiation of anemia treatment (Erythropoiesis-Stimulating Agents (ESAs), Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH) inhibitors, iron preparations, or red blood cell (RBC) transfusion
- Secondary Outcome Measures
Name Time Method Number of administered doses of ESA, HIF-PH inhibitors, iron preparations, and RBC transfusions Up to 24 months Erythropoiesis-Stimulating Agents (ESAs) Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH) Red blood cell (RBC) transfusions
Anemia-related healthcare costs Up to 24 months Anemia-related medical costs are defined as the sum of direct medical costs associated with the treatment of anemia. These costs will include medication costs and costs related to RBC transfusion.
Frequency of administration of ESA, HIF-PH inhibitors, iron preparations, and RBC transfusions Up to 24 months
Trial Locations
- Locations (1)
Nippon Boehringer Ingelheim Co ., Ltd.
🇯🇵Tokyo, Japan
Nippon Boehringer Ingelheim Co ., Ltd.🇯🇵Tokyo, Japan