Chronic Kidney Disease22663NCT06608212
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Care in the United States
An observational study of Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 1 site in United States.
Trial summary
This is an observational study in which data from people with chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D) are collected and studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare. 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, BAY948862) and Others except finerenone
- How many people
- 238,038 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2024to 26 Jun 2026
- 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: Adults with CKD and T2D who are eligible for finerenone prescription after the approval of finerenone in the US. The study cohort will identify patients who initiate finerenone and a comparator group of individuals with CKD and T2D not using finerenone. All eligible adult individuals (aged ≥ 18 years) in the data source will be selected for the study cohort without sampling from the source population. There will be no restrictions of the study population based on sex, race, or ethnicity.
Who may be able to join
None listed.
Who cannot join
- Finerenone users who are hospitalized or admitted for an emergency department visit on Time 0
- Type 1 diabetes (T1D) at any time on or before Time
- Evidence of end-stage kidney disease (ESKD) at any time on or before Time 0
- A diagnosis of kidney cancer at any time on or before Time 0
- A diagnosis of adrenal insufficiency at any time on or before Time 0
- Evidence of hepatic impairment at any time on or before Time 0
Show all 10Show fewer
- An eGFR measurement < 25 mL/min/1.73 m^2 on or in the 90 days before Time 0
- Evidence of recent increased serum potassium or hyperkalaemia
- Use of a strong CYP3A4 inhibitor on or in the 183 days before Time 0
- Evidence of pregnancy measured on or in the 40 weeks before Time 0
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FIRST-2.5: Finerenone Research of Early Safety and Effectiveness, Part 2.5
This is an observational study in which data from people with chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D) are collected and studied.
In observational studies, only observations are made without participants receiving any advice or any changes to healthcare.
Read more
CKD is a long-term condition in which the kidneys' ability to work properly gradually decreases over time. It is common in people with Type 2 diabetes mellitus (T2D), a condition in which glucose levels rise in the blood. People who have T2D and CKD may also develop heart disease over time.
The study drug, finerenone, is already approved for doctors to prescribe to people with CKD and T2D in the US. It blocks the activity of a protein involved in worsening kidney function.
The participants in this study are allowed to take finerenone as part of their regular care from their doctors.
The main purpose of the study is to learn about how safe finerenone is and how well it works in people with CKD and T2D in routine medical care. To do this, researchers will collect information about the time to first occurrence of any of the following heart-related problems for participants in the US who are taking finerenone and those who are not taking it:
- Heart attacks
- Hospitalization due to heart failure The data will come from the electronic healthcare records of people with CKD and T2D in the US who are allowed to take finerenone after July 2021.
Researchers will track participants' data and will follow them until the occurrence of heart-related problems, the participant's data is no longer available, there is a change in the participant's treatment strategy, or the end of the study.
In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Being tested
- Finerenone (Kerendia, BAY948862), Others except finerenone
- Keywords
- CKD, T2DM
- 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, BAY948862)Drug
Follow clinical practice/administration.
Others except finerenoneDrug
Follow clinical practice/administration. The non-use finerenone treatment strategy will require individuals to be free of finerenone use.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone group | Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) initiating finerenone. Retrospective analysis using secondary data collection from existing healthcare data from the US. Considered data sources include the HealthVerity Chronic Kidney Disease Masterset Receives: Drug: Finerenone (Kerendia, BAY948862) | |
| Comparator group | Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) not using finerenone. Retrospective analysis using secondary data collection from existing healthcare data from the US. Considered data sources include the HealthVerity Chronic Kidney Disease Masterset Receives: Drug: Others except finerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first occurrence of composite cardiovascular outcome
The composite cardiovascular outcome includes an inpatient hospital diagnosis of fatal or nonfatal acute myocardial infarction or an inpatient hospitalisation with a primary diagnosis of heart failure.
Measured: Retrospective analysis from July 2021 to June 2025
Secondary outcomes (5)
Time to the first occurrence of an inpatient hospital diagnosis of fatal or nonfatal acute myocardial infarction
Measured: Retrospective analysis from July 2021 to June 2025
Time to the first occurrence of an inpatient hospitalisation with a primary diagnosis of heart failure
Measured: Retrospective analysis from July 2021 to June 2025
Time to the first occurrence of an inpatient hospital or emergency department diagnosis of heart failure for participants without a history of heart failure
Measured: Retrospective analysis from July 2021 to June 2025
Time to occurrence of specific Urine Albumin-Creatine Ratio (UACR) decline thresholds
Measured: Retrospective analysis from July 2021 to June 2025
Time to the first occurrence of a hospitalisation or emergency department visit with a diagnosis code for hyperkalaemia
Measured: Retrospective analysis from July 2021 to June 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start9 Oct 2024
- Primary completion31 Mar 2025
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 238,038 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608212
- Sponsor's protocol ID
- 22663
- Acronym
- 22663
- Status last verified
- 13 Oct 2026
- First submitted
- 19 Sep 2024
- Last updated
- 16 Oct 2026
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIRST-2.5: Finerenone Research of Early Safety and Effectiveness, Part 2.5
- ClinicalTrials.gov ID
- NCT06608212
- Acronym / sponsor ID
- 22663 / 22663
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Keywords
- CKD, T2DM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 238,038 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 23 Sep 2024 (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 mellitus (T2D) are collected and studied.
In observational studies, only observations are made without participants receiving any advice or any changes to healthcare.
CKD is a long-term condition in which the kidneys' ability to work properly gradually decreases over time. It is common in people with Type 2 diabetes mellitus (T2D), a condition in which glucose levels rise in the blood. People who have T2D and CKD may also develop heart disease over time.
The study drug, finerenone, is already approved for doctors to prescribe to people with CKD and T2D in the US. It blocks the activity of a protein involved in worsening kidney function.
The participants in this study are allowed to take finerenone as part of their regular care from their doctors.
The main purpose of the study is to learn about how safe finerenone is and how well it works in people with CKD and T2D in routine medical care. To do this, researchers will collect information about the time to first occurrence of any of the following heart-related problems for participants in the US who are taking finerenone and those who are not taking it:
- Heart attacks
- Hospitalization due to heart failure The data will come from the electronic healthcare records of people with CKD and T2D in the US who are allowed to take finerenone after July 2021.
Researchers will track participants' data and will follow them until the occurrence of heart-related problems, the participant's data is no longer available, there is a change in the participant's treatment strategy, or the end of the study.
In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finerenone group | – | Drug: Finerenone (Kerendia, BAY948862)Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) initiating finerenone. Retrospective analysis using secondary data collection from existing healthcare data from the US. Considered data sources include the HealthVerity Chronic Kidney Disease Masterset |
| Comparator group | – | Drug: Others except finerenonePatients with chronic kidney disease (CKD) and type 2 diabetes (T2D) not using finerenone. Retrospective analysis using secondary data collection from existing healthcare data from the US. Considered data sources include the HealthVerity Chronic Kidney Disease Masterset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with CKD and T2D who are eligible for finerenone prescription after the approval of finerenone in the US. The study cohort will identify patients who initiate finerenone and a comparator group of individuals with CKD and T2D not using finerenone. All eligible adult individuals (aged ≥ 18 years) in the data source will be selected for the study cohort without sampling from the source population. There will be no restrictions of the study population based on sex, race, or ethnicity.
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Finerenone users who are hospitalized or admitted for an emergency department visit on Time 0
- Type 1 diabetes (T1D) at any time on or before Time
- Evidence of end-stage kidney disease (ESKD) at any time on or before Time 0
- A diagnosis of kidney cancer at any time on or before Time 0
- A diagnosis of adrenal insufficiency at any time on or before Time 0
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, BAY948862)Follow clinical practice/administration. | Drug | Finerenone group |
| Others except finerenoneFollow clinical practice/administration. The non-use finerenone treatment strategy will require individuals to be free of finerenone use. | Drug | Comparator group |
Primary outcome
Time to the first occurrence of composite cardiovascular outcome
Time frame: Retrospective analysis from July 2021 to June 2025
The composite cardiovascular outcome includes an inpatient hospital diagnosis of fatal or nonfatal acute myocardial infarction or an inpatient hospitalisation with a primary diagnosis of heart failure.
5 secondary outcomes
Time to the first occurrence of an inpatient hospital diagnosis of fatal or nonfatal acute myocardial infarction
Time frame: Retrospective analysis from July 2021 to June 2025
Time to the first occurrence of an inpatient hospitalisation with a primary diagnosis of heart failure
Time frame: Retrospective analysis from July 2021 to June 2025
Time to the first occurrence of an inpatient hospital or emergency department diagnosis of heart failure for participants without a history of heart failure
Time frame: Retrospective analysis from July 2021 to June 2025
Time to occurrence of specific Urine Albumin-Creatine Ratio (UACR) decline thresholds
Time frame: Retrospective analysis from July 2021 to June 2025
Time to the first occurrence of a hospitalisation or emergency department visit with a diagnosis code for hyperkalaemia
Time frame: Retrospective analysis from July 2021 to June 2025
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 16 Oct 2026.
- 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.
1 site in 1 country: 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 1 site in United States.
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 0 inclusion and 10 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Time to the first occurrence of composite cardiovascular outcome (time frame: Retrospective analysis from July 2021 to June 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.