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Active, Not Recruiting

NCT Number: NCT06527846

Post Marketing Surveillance of JARDIANCE in Chronic Kidney Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Kidney Disease, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, 1416017, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JARDIANCE®

Drug

JARDIANCE®

Other names: Empagliflozin

Primary outcomes

  1. Incidence of Adverse Drug Reactions (ADRs)

    Time frame: Up to 52 weeks

Secondary outcomes

  1. Kidney disease progression

    Time frame: Up to 52 weeks

    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.

  2. Incidence of cardiovascular death

    Time frame: Up to 52 weeks

  3. Incidence of all cause death

    Time frame: Up to 52 weeks

  4. Incidence of hospitalization for heart failure

    Time frame: Up to 52 weeks

  5. Change from baseline in eGFR to the last observation on treatment

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Post Marketing Surveillance on Long Term Use of JARDIANCE® Tablets in Patients With Chronic Kidney Disease in Japan

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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