Status: Ongoing First registered on: 22/08/2022
Last updated on: 10/10/2022
1. Study identification
EU PAS Register NumberEUPAS48148
Official titleFINErenone druG Utilization Study and assessment of Temporal changes following availability of different treatment options in patients with chronic kidney disease and type 2 diabetes
Study title acronymFINEGUST
Study typeObservational study
Brief description of the studyThis 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
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagehttps://www.rtihs.org/services/pharmacoepidemiology-and-risk-management
Details of (Primary) lead investigator
Title Dr
Last name Perez-Gutthann
First name Susana
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?6

CPRD
PHARMO Institute
Aarhus University Dept. of Clinical Epidemiology
FISABIO, Spain
The Japan Chronic Kidney Disease Database Extension, Japan
Optum Clinformatics® DataMart, US
Countries in which this study is being conducted
International study

Denmark
Japan
Netherlands
Spain
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed31/05/202206/05/2022
Start date of data collection01/10/202201/10/2022
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2024
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name BAYER AG
First name Bayer Clinical Trials
Address line 1Muellerstrasse 178
Address line 2 
Address line 3 
CityBerlin 
Postcode 
CountryGermany
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address clinical-trials-contact@bayer.com
Public Enquiries
Title Dr 
Last name BAYER AG 
First name Bayer Clinical Trials 
Address line 1Muellerstrasse 178 
Address line 2 
Address line 3 
CityBerlin 
Postcode 
CountryGermany 
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address clinical-trials-contact@bayer.com 
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