Dapagliflozin Post Marketing Surveillance in HF and CKD

Completed

• Conditions: Heart Failure; Chronic Kidney Disease

• Registration Number: NCT05134701
• Lead Sponsor: AstraZeneca

Brief 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

Detailed 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

Study Timeline

• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-26
• Study Start: 2022-03-10
• Primary Completion: 2024-05-20
• Study Completion: 2024-05-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 815

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
No worsening in UACR category from baseline	12 weeks or 24 weeks
No worsening in NYHA class from baseline	12 weeks or 24 weeks

Trial Locations

Locations (1)

Research Site; 🇰🇷 Uijeongbu-si, Korea, Republic of