Study identification

PURI

https://redirect.ema.europa.eu/resource/49285

EU PAS number

EUPAS48148

Study ID

49285

Official title and acronym

FINErenone druG Utilization Study and assessment of Temporal changes following availability of different treatment options in patients with chronic kidney disease and type 2 diabetes (FINEGUST)

DARWIN EU® study

No

Study countries

Denmark
Japan
Netherlands
Spain
United Kingdom
United States

Study description

This is an observational study in people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who have already started or will start one of the following treatments for T2D or CKD: Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Glucagon-like peptide-1 receptor agonists (GLP-1 RA), Steroidal mineralocorticoid receptor antagonists (sMRA), Finerenone a non-steroidal mineralocorticoid receptor antagonist (nsMRA), Other nsMRA (only in Japan). The main purpose of the study is to collect and describe characteristics of patients in each treatment group before and after finerenone became available. To do this, the researchers will collect data on: • Patient characteristics (e.g., age sex) of the participants • Clinical characteristics (e.g., history of CKD and T2D, heart and liver health, other health problems) of the participants • Treatments for T2D and CKD • Other medications used Data will be grouped by type of treatment that is initiated (e.g., SGLT2i, a GLP-1 RA, a sMRA, finerenone, or other nsMRA). Two time periods will be compared. Period I is the time until finerenone became available in the respective country, starting from 2012 (2014 for Japan). Period II will begin when finerenone becomes available in the respective country and will end at the end of the study (planned in September 2024). Researchers will also collect data on treatment patterns and changes in baseline characteristics in both time periods. Existing health care data will be collected from various sources in six countries (e.g., Denmark, Japan, the Netherlands, Spain, UK, and US). Besides this data collection, no further tests or examinations are planned in the study. The patients will receive their treatment as prescribed by their doctors during routine practice. Each patient will be in the study from first use of one of the listed drug classes until: • End of study • The data are somehow no longer available • The patient leaves or has to leave the study

Study status

Ongoing
Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner
Optum
Germany
First published:
07/02/2014
Institution
OtherENCePP partner
FISABIO Spain, The Japan Chronic Kidney Disease Database Extension Japan, Optum Clinformatics® DataMart US

Contact details

Catherine Johannes

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bayer AG
Study protocol
Initial protocol
English (812.13 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable