An observational study in Heart Failure and Chronic Kidney Disease, sponsored by AstraZeneca. Completed at 26 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by AstraZeneca · Observational
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
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 with the product in accordance with the newly updated local prescribing information for HF 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 (HF) 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 in Korean patients with 1) HF and/or 2) CKD 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 newly approved indication(s) in Korean patients with 1) HF and/or 2) CKD during the 12 weeks or about 24 weeks of follow-up duration.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 815 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
On active study drug treatment according to the approved local label.
Exclusion Criteria:
Incidence (%) of adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs, unexpected SAEs, SADRs
Time frame: 12weeks or 24weeks
No worsening in NYHA class from baseline
Time frame: 12 weeks or 24 weeks
No worsening in UACR category from baseline
Time frame: 12 weeks or 24 weeks
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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