An Observational Study, Called FINEGUST, to Learn More About How People With Chronic Kidney Disease and Type 2 Diabetes Are Treated and How the Introduction of New Treatment Options, Like Finerenone, Impacts Clinical Practice

NCT ID: NCT05526157

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-09-05

Brief Summary

This is an observational study in which data from people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who have already started or will start CKD or T2D treatment are collected and studied. In observational studies, only observations are made without specified advice or interventions.

People receiving the following CKD or T2D treatments as recommended by their doctors will be included:

• 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)

Kidneys filter extra water and waste from the blood and make urine. CKD is a long-term, progressive decrease in the kidneys' ability to properly filter blood. In people with T2D, the body does not make enough of a hormone called insulin or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D.

The new drug, finerenone, works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys. By lowering their stimulation, finerenone reduces the risk of progressive worsening of the kidney disease.

Finerenone is available and approved in several countries for doctors to prescribe to people with CKD and T2D.

The main purpose of the study is to collect and describe characteristics of participants in each treatment group who have started or will start treatment 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. Study period I is the time until finerenone became available in the respective country, starting from 2012 (2014 for Japan). Study 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 for each type of treatment in both time periods.

Health care data will be collected from various sources in five countries (e.g., Denmark, the Netherlands, Spain, Japan, and the US).

The patients will receive their treatment as prescribed by their doctors during routine practice according to the approved product information.

Each patient will be in the study from first use (in Study period I and II) 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

Conditions

Chronic Kidney Disease; Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with CKD+T2D in Study period I

In the pre-finerenone approval period (Study period I), 4 new-user cohorts to be identified, based on the first use of any drug in these classes: SGLT2i, GLP-1 RA, sMRA, or nsMRA.

Sodium-glucose cotransporter 2 inhibitors (SGLT2i)

Intervention Type: DRUG

Retrospective analysis using secondary data collection from various sources

Glucagon-like peptide-1 receptor agonists (GLP 1 RA)

Intervention Type: DRUG

Retrospective analysis using secondary data collection from various sources

Steroidal mineral corticoid receptor antagonists (sMRA)

Intervention Type: DRUG

Retrospective analysis using secondary data collection from various sources

Non-steroidal mineral corticoid receptor antagonists (nsMRA)

Intervention Type: DRUG

Retrospective analysis using secondary data collection from various sources

Patients with CKD+T2D in Study period II

In the post-finerenone study period (study period II), 3 new-user cohorts will be identified: SGLT2i, GLP-1 RA, and finerenone.

Finerenone (Kerendia, BAY 948862)

Intervention Type: DRUG

Retrospective analysis using secondary data collection from various sources

Sodium-glucose cotransporter 2 inhibitors (SGLT2i)

Intervention Type: DRUG

Retrospective analysis using secondary data collection from various sources

Glucagon-like peptide-1 receptor agonists (GLP 1 RA)

Intervention Type: DRUG

Retrospective analysis using secondary data collection from various sources

Interventions

Finerenone (Kerendia, BAY 948862)

Retrospective analysis using secondary data collection from various sources

Intervention Type: DRUG

Sodium-glucose cotransporter 2 inhibitors (SGLT2i)

Retrospective analysis using secondary data collection from various sources

Intervention Type: DRUG

Glucagon-like peptide-1 receptor agonists (GLP 1 RA)

Retrospective analysis using secondary data collection from various sources

Intervention Type: DRUG

Steroidal mineral corticoid receptor antagonists (sMRA)

Retrospective analysis using secondary data collection from various sources

Intervention Type: DRUG

Non-steroidal mineral corticoid receptor antagonists (nsMRA)

Retrospective analysis using secondary data collection from various sources

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Active registration or continuous enrolment for at least 12 months in 1 of the selected data sources before the index date
• No recorded prescription or dispensing of any medication in the class during the 12 months before the index date
• Age 18 years or older as of the index date
• Diagnosis of T2D on or before the index date
• Diagnosis of CKD on or before the index date

Exclusion Criteria

• Type 1 diabetes identified by appropriate algorithms in each participating data source
• Kidney cancer on or before the index date
• Kidney failure

-- Maintenance dialysis on or before the index date

• Kidney transplantation on or before the index date

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Optum CDM

Eden Prairie, Minnesota, United States

Many Locations

Multiple Locations, , Denmark

Many Locations

Multiple Locations, , Japan

Many Locations

Multiple Locations, , Netherlands

Many Locations

Multiple Locations, , Spain

Countries

United States; Denmark; Japan; Netherlands; Spain

Related Links

https://clinicaltrials.bayer.com/

Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Other Identifiers

21956

Identifier Type: -

Identifier Source: org_study_id