SGLT2 Inhibitors and Renal Anemia in Japan: RWD

Boehringer Ingelheim

Status: Active, not recruiting

Conditions: Chronic Kidney Disease

Treatments: Drug: SGLT2 inhibitor

Study type: Observational

Funder types: Industry

Identifiers

NCT07063316

1245-0387

Details and patient eligibility

About

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.

Enrollment: 15,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

15,000 participants in 2 patient groups

SGLT2 inhibitor users

Treatment:

Drug: SGLT2 inhibitor

SGLT2 inhibitor non-users