Chronic Kidney DiseaseFINEGUSTNCT05526157
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
An observational study of Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 5 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- What is being tested?
- Finerenone (Kerendia, BAY 948862), Sodium-glucose cotransporter 2 inhibitors (SGLT2i) and Glucagon-like peptide-1 receptor agonists (GLP 1 RA)
- How many people
- 50,000 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Oct 2022to 5 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted using data from data sources in 5 countries: Denmark (the Danish National Health Registers), Japan (the Japan Chronic Kidney Disease Database), the Netherlands (PHARMO), Spain (the Valencia Health System Integrated Database), and the US (Optum). For each database, the source population will include patients who fulfil an electronic algorithm for CKD and T2D.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: 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
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:
Read more
- 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
- Being tested
- Finerenone (Kerendia, BAY 948862), Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Glucagon-like peptide-1 receptor agonists (GLP 1 RA), Steroidal mineral corticoid receptor antagonists (sMRA), Non-steroidal mineral corticoid receptor antagonists (nsMRA)
- Keywords
- Chronic kidney disease, Type 2 diabetes mellitus, Impaired kidney function, Non-steroidal mineralocorticoid receptor antagonist (nsMRA)
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finerenone (Kerendia, BAY 948862)Drug
Retrospective analysis using secondary data collection from various sources
Sodium-glucose cotransporter 2 inhibitors (SGLT2i)Drug
Retrospective analysis using secondary data collection from various sources
Glucagon-like peptide-1 receptor agonists (GLP 1 RA)Drug
Retrospective analysis using secondary data collection from various sources
Steroidal mineral corticoid receptor antagonists (sMRA)Drug
Retrospective analysis using secondary data collection from various sources
Non-steroidal mineral corticoid receptor antagonists (nsMRA)Drug
Retrospective analysis using secondary data collection from various sources
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sodium-glucose cotransporter 2 inhibitors (SGLT2i); Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA); Drug: Steroidal mineral corticoid receptor antagonists (sMRA); Drug: Non-steroidal mineral corticoid receptor antagonists (nsMRA) | |
| 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. Receives: Drug: Finerenone (Kerendia, BAY 948862); Drug: Sodium-glucose cotransporter 2 inhibitors (SGLT2i); Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive summary of baseline patient characteristics
Demographic (Age, Sex, Race and Socioeconomic status ) and clinical characteristics (markers of severity of T2D and of kidney dysfunction ) data will be collected.
Measured: Baseline study periods I and II
Descriptive summary of patient comorbidities
History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, hypertension, hypercholesterolemia, Congestive heart failure, Severe liver disease, Other comorbidities measured by the Charlson or similar comorbidity indices. Lifestyle factors as Body mass index (BMI) or evidence of obesity, Smoking status, and alcohol abuse and alcohol abuse-related conditions, as available in each data source.
Measured: Baseline study periods I and II
Descriptive summary of patient comedications
Medications for T2D, CKD and other relevant medications.
Measured: Baseline study periods I and II
Secondary outcomes (2)
Descriptive summary of changes over time in treatments in the new-user cohorts
Measured: From Day 1 until Censor Day (at the earliest of death, disenrolment, exclusion criteria during follow-up, or end of the study period) [up to 114 months for study period I and up to 39 months for study period II].
Descriptive summary of temporal changes in the baseline characteristics of medication-specific cohorts
Measured: Baseline up to 114 months for study period I and up to 39 months for study period II
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Oct 2022
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526157
- Sponsor's protocol ID
- 21956
- Acronym
- FINEGUST
- Status last verified
- Oct 2024
- First submitted
- 19 Aug 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Johannes CB, Coleman CI, Kovesdy CP, Khan AM, Ziemiecki R, Layton JB, Vizcaya D, Liu F, Oberprieler NG. Temporal Changes in SGLT2 Inhibitor and GLP-1 Receptor Agonist Use in Patients with Chronic Kidney Disease and Type 2 Diabetes, 2012-2023: A US Cohort Study. Diabetes Ther. 2026 Feb;17(2):231-250. doi: 10.1007/s13300-025-01825-5. Epub 2025 Dec 9.
PubMed 41364416
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05526157
- Acronym / sponsor ID
- FINEGUST / 21956
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Keywords
- Chronic kidney disease, Type 2 diabetes mellitus, Impaired kidney function, Non-steroidal mineralocorticoid receptor antagonist (nsMRA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50,000 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with CKD+T2D in Study period I | – | Drug: Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA), Drug: Steroidal mineral corticoid receptor antagonists (sMRA), Drug: Non-steroidal mineral corticoid receptor antagonists (nsMRA)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. |
| Patients with CKD+T2D in Study period II | – | Drug: Finerenone (Kerendia, BAY 948862), Drug: Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA)In the post-finerenone study period (study period II), 3 new-user cohorts will be identified: SGLT2i, GLP-1 RA, and finerenone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted using data from data sources in 5 countries: Denmark (the Danish National Health Registers), Japan (the Japan Chronic Kidney Disease Database), the Netherlands (PHARMO), Spain (the Valencia Health System Integrated Database), and the US (Optum). For each database, the source population will include patients who fulfil an electronic algorithm for CKD and T2D.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finerenone (Kerendia, BAY 948862)Retrospective analysis using secondary data collection from various sources | Drug | Patients with CKD+T2D in Study period II |
| Sodium-glucose cotransporter 2 inhibitors (SGLT2i)Retrospective analysis using secondary data collection from various sources | Drug | Patients with CKD+T2D in Study period I, Patients with CKD+T2D in Study period II |
| Glucagon-like peptide-1 receptor agonists (GLP 1 RA)Retrospective analysis using secondary data collection from various sources | Drug | Patients with CKD+T2D in Study period I, Patients with CKD+T2D in Study period II |
| Steroidal mineral corticoid receptor antagonists (sMRA)Retrospective analysis using secondary data collection from various sources | Drug | Patients with CKD+T2D in Study period I |
| Non-steroidal mineral corticoid receptor antagonists (nsMRA)Retrospective analysis using secondary data collection from various sources | Drug | Patients with CKD+T2D in Study period I |
Primary outcome
Descriptive summary of baseline patient characteristics
Time frame: Baseline study periods I and II
Demographic (Age, Sex, Race and Socioeconomic status ) and clinical characteristics (markers of severity of T2D and of kidney dysfunction ) data will be collected.
Descriptive summary of patient comorbidities
Time frame: Baseline study periods I and II
History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, hypertension, hypercholesterolemia, Congestive heart failure, Severe liver disease, Other comorbidities measured by the Charlson or similar comorbidity indices. Lifestyle factors as Body mass index (BMI) or evidence of obesity, Smoking status, and alcohol abuse and alcohol abuse-related conditions, as available in each data source.
Descriptive summary of patient comedications
Time frame: Baseline study periods I and II
Medications for T2D, CKD and other relevant medications.
2 secondary outcomes
Descriptive summary of changes over time in treatments in the new-user cohorts
Time frame: From Day 1 until Censor Day (at the earliest of death, disenrolment, exclusion criteria during follow-up, or end of the study period) [up to 114 months for study period I and up to 39 months for study period II].
Descriptive summary of temporal changes in the baseline characteristics of medication-specific cohorts
Time frame: Baseline up to 114 months for study period I and up to 39 months for study period II
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 41364416Johannes CB, Coleman CI, Kovesdy CP, Khan AM, Ziemiecki R, Layton JB, Vizcaya D, Liu F, Oberprieler NG. Temporal Changes in SGLT2 Inhibitor and GLP-1 Receptor Agonist Use in Patients with Chronic Kidney Disease and Type 2 Diabetes, 2012-2023: A US Cohort Study. Diabetes Ther. 2026 Feb;17(2):231-250. doi: 10.1007/s13300-025-01825-5. Epub 2025 Dec 9.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Denmark, Japan, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive summary of baseline patient characteristics (time frame: Baseline study periods I and II). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05526157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.