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

NCT06287073 | Completed

• 2 other identifiers: 1245-0323EUPAS107293
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (13)

• Number of subjects with adverse events

  Up to 24 weeks

• Number of subjects with serious adverse event

  Up to 24 weeks

• Number of subjects with non-serious adverse events

  Up to 24 weeks

• Number of subjects with adverse drug reaction

  Up to 24 weeks

• Number of subjects with serious adverse drug reactions

  Up to 24 weeks

• Number of subjects with unexpected adverse events

  Up to 24 weeks

• Number of subjects with adverse events of special interest

  Adverse events of special interest are: liver injury, ketoacidosis in diabetic and nondiabetic population, lower limb amputation

  Up to 24 weeks

• Number of subjects with specific adverse events

  Specific adverse events are: severe hypoglycaemia, urinary tract infection, genital infection, bone fracture, urinary tract malignancy, volume depletion, acute kidney injury, gout, hyperkalaemia

  Up to 24 weeks

• Number of subjects with adverse events leading to temporary or permanent discontinuation

  Up to 24 weeks

• Number of subjects with adverse events by intensity

  Intensity is measured as: mild, moderate, severe

  Up to 24 weeks

• Number of subjects with adverse events by outcome of the events

  Outcome of the event is measured as: recovered, not yet recovered, sequela, fatal, unknown

  Up to 24 weeks

• Number of subjects with adverse events by causality

  Causality is measured as: certain, probable·likely, possible, unlikely, conditional· unclassified, unassessable·unclassifiable

  Up to 24 weeks

• Number of subjects with adverse events leading to death

  Up to 24 weeks

Secondary Outcomes (1)

• Occurrence of change in urine albumin-creatinine ratio (UACR) from baseline after 12 weeks and/or 24 weeks of treatment

  at baseline, at Week 12, and at Week 24

Study Arms (1)

New JARDIANCE® users with chronic kidney disease (CKD)

Patients with CKD starting JARDIANCE® for the first time in accordance with the approved label in Korea

Drug: JARDIANCE®

Interventions

JARDIANCE® DRUG

JARDIANCE®

New JARDIANCE® users with chronic kidney disease (CKD)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a single-arm, open-label, multi-centre observational and non-interventional study (ONIS) based on newly collected data. This study will be carried out by enrolling patients in a consecutive manner into the study requiring completion of case report forms (CRFs) for all participants who initially administered JARDIANCE® following the study start date until the planned number of participants is reached.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (12)

Hallym University Sacred Heart Hospital

Anyang, 07441, South Korea

Location

Chungbuk National University Hospital

Cheongiu, 28644, South Korea

Location

Yonsei University Wonju Severance Christian Hospital

Gangwon, 26426, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang, 10380, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, 03312, South Korea

Location

Soonchunhyang University Hospital Seoul

Seoul, 04401, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea, Yeouido St.Mary's Hospital

Seoul, 07345, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: February 29, 2024
• Study Start: March 29, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents upon signing of a 'Document Sharing Agreement'. For study data 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

KR (12)