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OpenTrials
Completed

NCT Number: NCT06287073

JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD)

The primary objective is to monitor the safety profile of JARDIANCE® in Korean patient with chronic kidney disease (CKD) in routine clinical practice.

The secondary objective is to monitor the efficacy of JARDIANCE® by evaluating changes in urine albumin-creatinine ratio (UACR) after 12 and/or 24 weeks of treatment.

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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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hallym University Sacred Heart Hospital, Anyang, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≧19 years at enrolment
  • Patients diagnosed with CKD
  • Patients with CKD starting JARDIANCE® for the first time in accordance with the approved label in Korea
  • Patients who have provided informed consent and signed the data release consent form

Exclusion criteria

  • Patients with previous exposure to JARDIANCE®
  • Patients with hypersensitivity to empagliflozin or to any of the excipients
  • Patients with type 1 diabetes
  • Patients with history of Diabetic Ketoacidosis (DKA)
  • Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
  • Patients who are pregnant or are breastfeeding or who plan to become pregnant during the study period

Treatment and study plan

JARDIANCE®

Drug

JARDIANCE®

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 337 days.

    Number of participants with adverse events (AEs).

  2. Number of Participants With Serious Adverse Event (SAEs)

    Time frame: Up to 337 days.

    Number of participants with serious adverse event (SAEs).

  3. Number of Participants With Non-serious Adverse Events

    Time frame: Up to 337 days.

    Number of participants with non-serious adverse events.

  4. Number of Participants With Adverse Drug Reaction (ADR)s

    Time frame: Up to 337 days.

    Number of participants with adverse drug reaction (ADR)s.

  5. Number of Participants With Serious Adverse Drug Reactions

    Time frame: Up to 337 days.

    Number of participants with serious adverse drug reactions.

  6. Number of Participants With Unexpected Adverse Events

    Time frame: Up to 337 days.

    Number of participants with unexpected adverse events.

  7. Number of Participants With Adverse Events of Special Interest (AESIs)

    Time frame: Up to 337 days.

    Adverse events of special interest (AESIs) consist of: Liver injury, Ketoacidosis in diabetic and nondiabetic population, Lower limb amputation.

  8. Number of Participants With Specific Adverse Events

    Time frame: Up to 337 days.

    Specific adverse events consist of: Severe hypoglycaemia, Urinary tract infection, Genital infection, Bone fracture, Urinary tract malignancy, Volume depletion, Acute kidney injury, Gout, Hyperkalaemia.

  9. Number of Participants With Adverse Events Leading to Temporary or Permanent Discontinuation

    Time frame: Up to 337 days.

    Number of participants with adverse events leading to temporary or permanent discontinuation.

  10. Number of Participants With Adverse Events by Intensity

    Time frame: Up to 337 days.

    Number of participants with adverse events by intensity.

  11. Number of Participants With Adverse Events by Outcome of the Events

    Time frame: Up to 337 days.

    Number of participants with adverse events by outcome of the events.

  12. Number of Participants With Adverse Events by Causality

    Time frame: Up to 337 days.

    Number of participants with adverse events by causality.

  13. Number of Participants With Adverse Events Leading to Death

    Time frame: Up to 337 days.

    Number of participants with adverse events leading to death.

Secondary outcomes

  1. Change in Urine Albumin-Creatinine Ratio (UACR) From Baseline After 12 Weeks and 24 Weeks of Treatment

    Time frame: Data collected at baseline (visit 1), week 12 and week 24.

    Change in Urine Albumin-Creatinine Ratio (UACR) from baseline after 12 weeks and 24 weeks of treatment. UACR is calculated as albumin (milligrams)/creatinine (grams)

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Regulatory Non-interventional Study to Monitor the Safety and Efficacy of JARDIANCE® (Empagliflozin 10 mg) in Korean Patients With Chronic Kidney Disease (CKD)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 29, 2024
Registry last updated
Jun 23, 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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