Dapagliflozin Post Marketing Surveillance in HF and CKD

Dapagliflozin Post-Marketing Surveillance in Heart Failure Patients and Chronic Kidney Disease Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05134701

Enrollment

815

Registered

2021-11-26

Start date

2022-03-10

Completion date

2024-05-20

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Heart Failure

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 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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 HF 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
No worsening in NYHA class from baseline	12 weeks or 24 weeks
No worsening in UACR category from baseline	12 weeks or 24 weeks

Countries

South Korea

Outcome results