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NCT05134701 Clinical Trial

Dapagliflozin Post Marketing Surveillance in HF and CKD

Chronic Kidney Disease Clinical Trial

Official title:
Dapagliflozin Post-Marketing Surveillance in Heart Failure With Reduced Ejection Fraction Patients and Chronic Kidney Disease Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05134701
Other study ID # D1699R00007
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 10, 2022
Est. completion date May 30, 2024

Study information
Verified date February 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational, non-interventional, single-arm multicenter study. The objectives of this study are to assess safety and effectiveness of Forxiga in a real world setting in patients who are prescribed with the study drug according to the newly approved indications in the Republic of Korea

Description:

As part of a post-approval commitment, the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (hereinafter "Korea") requests a study to characterize the safety in patients treated with dapagliflozin by physicians in normal clinical practice settings. In principle, all patients treated (minimum of 900 required) with the product in accordance with the newly updated local prescribing information for HFrEF and/or CKD are eligible for the enrolment in this study. Product prescription and patient enrollment will depend on physicians' medical decision as per routine clinical practice. Patient follow-up will be 12 weeks or about 24 weeks (for long-term surveillance) and patients will be recruited over a period of 4 years after the new HFrEF indication approval by the local health authorities. This is due to the requirements from the local health authorities. The primary objective of this study is to assess the safety profile of the product in Korean adult patients with heart failure with reduced ejection fraction (HFrEF) and/or chronic kidney disease (CKD) in a real world setting under the approved indication(s) in Korea. The secondary objective of this study is to examine the effectiveness of the product, measured as: 1) no worsening in NYHA class, in Korean patients with HFrEF and/or 2) no worsening in UACR category in Korean CKD patients in a real world setting under the approved indication(s) in Korea. The exploratory objective of this study is to identify patients' baseline characteristics that might be associated with the safety and effectiveness of the product when prescribed under the approved indication(s) in Korean patients with HFrEF and/or CKD during the 12 weeks or about 24 weeks of follow-up duration

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 815
Est. completion date May 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Patients aged 19 years old and older - Patients eligible for the product treatment (i.e. on-label treatment) according to the newly approved HFrEF and/or CKD label in Korea - Provision of signed and dated written informed consent by the patient or legally acceptable representative Exclusion Criteria: - Participation in any interventional trial during the treatment with the product. - Any off-label indications that are not in accordance with the newly approved label in Korea. - Any contraindications for the use of the product (as described in the local prescribing information). - Prior use of product, as per local MFDS guidance.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Research Site Busan
Korea, Republic of Research Site Busan
Korea, Republic of Research Site Busan
Korea, Republic of Research Site Changwon
Korea, Republic of Research Site Changwon
Korea, Republic of Research Site Daegu
Korea, Republic of Research Site Daegu
Korea, Republic of Research Site Daejeon
Korea, Republic of Research Site Daejeon
Korea, Republic of Research Site Daejeon-si
Korea, Republic of Research Site Gwangju
Korea, Republic of Research Site Iksan
Korea, Republic of Research Site Jeonju
Korea, Republic of Research Site Jeonju
Korea, Republic of Research Site Seongnam-si
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Suncheon
Korea, Republic of Research Site Suwon
Korea, Republic of Research Site Uijeongbu-si

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence (%) of adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs, unexpected SAEs, SADRs 12weeks or 24weeks
Secondary No worsening in NYHA class from baseline 12 weeks or 24 weeks
Secondary No worsening in UACR category from baseline 12 weeks or 24 weeks
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