Chronic Kidney DiseaseFIRST-2_CNNCT07124039
An Observational Study Called FIRST-2.0 China to Learn More About the Use of the Study Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions in a Chinese Population.
An observational study of Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 1 site in China.
Trial summary
This is a post-authorization safety study (PASS) to describe the real-world use of finerenone in patients with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2D) in China. The study will examine baseline characteristics, comorbidities, and comedications of patients who initiate finerenone treatment. 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)
- How many people
- 6,537 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2025to 28 Feb 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: Adult patients with chronic kidney disease and type 2 diabetes mellitus who initiate finerenone treatment in China
Who may be able to join
- Minimum of 12 months continuous enrolment before the index date in the database with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the electronic health record system
- No recorded prescription of finerenone prior to the index date
- Age 18 years or older as of the index date
- Diabetic kidney disease diagnosis by diagnosis texts at any point before (and including) the index date, OR
- T2D diagnosis at any point before (and including) the index date using the same algorithms as in previous studies of the FIRST program, AND
- CKD stages 2-4 related to eligibility will be defined according to the presence of the following criteria at any point before (and including) the index date:
Show all 10Show fewer
- A diagnosis code/text indicating CKD stage 2, 3, 4, or stage unspecified OR
- Two UACR test results ≥30 mg/g separated by at least 90 days and no more than 548 days.
- OR
- Two different eGFR test results ≥15 mL/min/1.73 m2 AND <60 mL/min/1.73 m2 separated by at least 90 days and no more than 548 days.
Who cannot join
- Type 1 diabetes mellitus identified by diagnosis codes/texts in the patient record on or before the index date
- Kidney cancer identified by diagnosis codes/texts on or before the index date
- Kidney failure on or before the index date, defined as:
- Two different eGFR test results <15 mL/min/1.73 m2 separated by at least 90 days and no more than 548 days OR
- Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period) OR
- A diagnosis code/text indicating kidney failure or CKD stage 5 OR
- A recorded diagnosis indicating kidney transplant
Trial locations and contacts
1 site in 1 country.
China1 site
Inspur Tianjin Regional Electronic Health Records Database
Tianjin, Tianjin Municipality, 301799
About this study
Official title: FIRST-2.0 China: Finerenone FIRST (Finerenone Research of Early Safety and Effectiveness), Part 2.0 in China
This is a post-authorization safety study (PASS) to describe the real-world use of finerenone in patients with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2D) in China. The study will examine baseline characteristics, comorbidities, and comedications of patients who initiate finerenone treatment. It will also evaluate changes in kidney function markers including estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), and serum potassium levels over time.
The study will assess hyperkalemia incidence, hospitalization rates associated with hyperkalemia, and finerenone dose titration patterns. This retrospective observational cohort study uses data from the Tianjin Healthcare and Medical Big Data Platform covering approximately 15 million residents.
The study aims to provide evidence on finerenone safety and effectiveness in routine clinical practice in China, complementing data from controlled clinical trials. Results will inform healthcare providers about real-world finerenone use patterns and outcomes in Chinese patients with diabetic kidney disease.
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Being tested
- Finerenone (Kerendia, BAY948862)
- 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
Retrospective cohort analysis using the EHR data from the Tianjin Healthcare and Medical Big Data Platform (China) database.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone users | Patients with chronic kidney disease and type 2 diabetes mellitus from China who initiate finerenone treatment. Receives: Drug: Finerenone (Kerendia, BAY948862) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in China.
Measured: Up to 365 days
Descriptive summary of comorbidities of patients who initiate finerenone and have CKD and T2D in China.
Measured: Up to 365 days
Descriptive summary of comedications of patients who initiate finerenone and have CKD and T2D in China.
Measured: Up to 180 days
Secondary outcomes (4)
To describe the routine monitoring of UACR, eGFR, and serum potassium before and after initiating finerenone in patients with CKD and T2D
Measured: Up to 32 months
To describe the absolute levels and relative changes over time of UACR, eGFR, and serum potassium after initiating finerenone in patients with CKD and T2D
Measured: Up to 32 months
To describe the incidence of hyperkalemia and the incidence of hospitalization associated with a hyperkalemia event after initiating finerenone in patients with CKD and T2D
Measured: Up to 32 months
To describe the number of patients who initiate finerenone using a 10 mg dose and the proportion of patients who have up-titrated to a 20 mg dose by 1, 3, 6, and 12 months, respectively, depending on data availability
Measured: Up to 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start16 Jul 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 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
- 6,537 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124039
- Sponsor's protocol ID
- 23030
- Acronym
- FIRST-2_CN
- Status last verified
- Apr 2026
- First submitted
- 8 Aug 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The 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 the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. 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. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIRST-2.0 China: Finerenone FIRST (Finerenone Research of Early Safety and Effectiveness), Part 2.0 in China
- ClinicalTrials.gov ID
- NCT07124039
- Acronym / sponsor ID
- FIRST-2_CN / 23030
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,537 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 15 Aug 2025 (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 a post-authorization safety study (PASS) to describe the real-world use of finerenone in patients with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2D) in China. The study will examine baseline characteristics, comorbidities, and comedications of patients who initiate finerenone treatment. It will also evaluate changes in kidney function markers including estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), and serum potassium levels over time.
The study will assess hyperkalemia incidence, hospitalization rates associated with hyperkalemia, and finerenone dose titration patterns. This retrospective observational cohort study uses data from the Tianjin Healthcare and Medical Big Data Platform covering approximately 15 million residents.
The study aims to provide evidence on finerenone safety and effectiveness in routine clinical practice in China, complementing data from controlled clinical trials. Results will inform healthcare providers about real-world finerenone use patterns and outcomes in Chinese patients with diabetic kidney disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Finerenone users | – | Drug: Finerenone (Kerendia, BAY948862)Patients with chronic kidney disease and type 2 diabetes mellitus from China who initiate finerenone treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic kidney disease and type 2 diabetes mellitus who initiate finerenone treatment in China
Key inclusion criteria (10 listed)
- Minimum of 12 months continuous enrolment before the index date in the database with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the electronic health record system
- No recorded prescription of finerenone prior to the index date
- Age 18 years or older as of the index date
- Diabetic kidney disease diagnosis by diagnosis texts at any point before (and including) the index date, OR
- T2D diagnosis at any point before (and including) the index date using the same algorithms as in previous studies of the FIRST program, AND
Key exclusion criteria (7 listed)
- Type 1 diabetes mellitus identified by diagnosis codes/texts in the patient record on or before the index date
- Kidney cancer identified by diagnosis codes/texts on or before the index date
- Kidney failure on or before the index date, defined as:
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)Retrospective cohort analysis using the EHR data from the Tianjin Healthcare and Medical Big Data Platform (China) database. | Drug | Finerenone users |
Primary outcome
Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in China.
Time frame: Up to 365 days
Descriptive summary of comorbidities of patients who initiate finerenone and have CKD and T2D in China.
Time frame: Up to 365 days
Descriptive summary of comedications of patients who initiate finerenone and have CKD and T2D in China.
Time frame: Up to 180 days
4 secondary outcomes
To describe the routine monitoring of UACR, eGFR, and serum potassium before and after initiating finerenone in patients with CKD and T2D
Time frame: Up to 32 months
To describe the absolute levels and relative changes over time of UACR, eGFR, and serum potassium after initiating finerenone in patients with CKD and T2D
Time frame: Up to 32 months
To describe the incidence of hyperkalemia and the incidence of hospitalization associated with a hyperkalemia event after initiating finerenone in patients with CKD and T2D
Time frame: Up to 32 months
To describe the number of patients who initiate finerenone using a 10 mg dose and the proportion of patients who have up-titrated to a 20 mg dose by 1, 3, 6, and 12 months, respectively, depending on data availability
Time frame: Up to 32 months
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 14 Apr 2026.
- Individual participant dataSharing planned: No. Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The 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 the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. 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. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies 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 China.
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 10 inclusion and 7 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 14 Apr 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 China. 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 characteristics of patients who initiate finerenone and have CKD and T2D in China. (time frame: Up to 365 days). 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?
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 14 Apr 2026.