Post Marketing Surveillance of JARDIANCE in Chronic Kidney Disease

N/AActive Not RecruitingNCT06527846

Boehringer Ingelheim1,024 enrolled

Overview

Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic kidney disease under real-world use.

Study Type

OBSERVATIONAL

Enrollment

1,024

Conditions

Kidney Disease, Chronic

Interventions

JARDIANCE®DRUG

JARDIANCE®

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with CKD who are prescribed JARDIANCE® Tablets for CKD according to the current Japanese package insert and who provided written informed consent prior to enrolment in this study. * Patients who have never been treated with JARDIANCE® Tablets (including treatment for Type 2 diabetes mellitus (T2DM) and/or chronic heart failure (CHF)) before enrolment. Exclusion Criteria: * None

Locations (1)

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, Japan

Outcomes

Primary Outcomes

Incidence of Adverse Drug Reactions (ADRs)

Time frame: Up to 52 weeks

Secondary Outcomes

Kidney disease progression

Kidney disease progression defined as incidence of end stage kidney disease (ESKD), a sustained decline in estimated glomerular filtration rate (eGFR) to \<10 mL/min/1.73 m\^2, renal death, or a sustained decline of ≥40% in eGFR from baseline). ESKD is defined as the initiation of maintenance dialysis or receipt of a kidney transplant.

Time frame: Up to 52 weeks

Incidence of cardiovascular death

Time frame: Up to 52 weeks

Incidence of all cause death

Time frame: Up to 52 weeks

Incidence of hospitalization for heart failure

Time frame: Up to 52 weeks

Change from baseline in eGFR to the last observation on treatment

Time frame: at baseline, at last observation on treatment (Up to 52 weeks)

Data from ClinicalTrials.gov

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