Clinical trial NCT06287073: JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD)
Official 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Disease, Chronic
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-02-29
Enrollment: 299
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: Up to 24 weeks
measure: Number of subjects with serious adverse event
timeFrame: Up to 24 weeks
measure: Number of subjects with non-serious adverse events
timeFrame: Up to 24 weeks
measure: Number of subjects with adverse drug reaction
timeFrame: Up to 24 weeks
measure: Number of subjects with serious adverse drug reactions
timeFrame: Up to 24 weeks
measure: Number of subjects with unexpected adverse events
timeFrame: Up to 24 weeks
measure: Number of subjects with adverse events of special interest
timeFrame: Up to 24 weeks
measure: Number of subjects with specific adverse events
timeFrame: Up to 24 weeks
measure: Number of subjects with adverse events leading to temporary or permanent discontinuation
timeFrame: Up to 24 weeks
measure: Number of subjects with adverse events by intensity
timeFrame: Up to 24 weeks
measure: Number of subjects with adverse events by outcome of the events
timeFrame: Up to 24 weeks
measure: Number of subjects with adverse events by causality
timeFrame: Up to 24 weeks
measure: Number of subjects with adverse events leading to death
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Occurrence of change in urine albumin-creatinine ratio (UACR) from baseline after 12 weeks and/or 24 weeks of treatment
timeFrame: at baseline, at Week 12, and at Week 24
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Cheongiu
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Gangwon
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital Seoul
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
References: