Type 2 DiabetesFINE-IMSS-MXNCT07841015
A Study to Learn More About How Well Finerenone Works in Real-world in People With Type 2 Diabetes and Chronic Kidney Disease in Primary Care (IMSS= Instituto Mexicano Del Seguro Social)
An observational study of Type 2 Diabetes and Chronic Kidney Disease (CKD) Stages G2 to G3b, run by Bayer at 1 site in Mexico.
Trial summary
The main purpose of this study is to learn how treatment with finerenone affects the urinary albumin-to-creatinine ratio (uACR), a marker of kidney health, over time in adults with type 2 diabetes and chronic kidney disease who are receiving care in primary care clinics as part of their usual medical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Chronic Kidney Disease (CKD) Stages G2 to G3b
- What is being tested?
- Finerenone
- How many people
- 800 participants
- Where
- 1 siteMexico
- Study dates
- 30 Oct 2026to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 aged ≥18 years with T2D and CKD, of both sexes, treated in IMSS primary care units, who start treatment with finerenone as part of routine clinical practice.
Who may be able to join
- Adult participant - all genders (>=18 years old).
- Documented diagnosis of Type 2 diabetes (T2D), according to clinical criteria used in routine clinical practice.
- Documented diagnosis of Chronic Kidney Disease (CKD) in stages G2 to G3b, defined by an estimated glomerular filtration rate (Estimated Glomerular Filtration Rate [eGFR] >=30 and <90 mL/min/1.73 m^2 according to the information available in the clinical record).
- Baseline urinary albumin-to-creatinine ratio (uACR) value >=30 mg/g, documented at the time of inclusion in the study.
- Decision to initiate treatment with finerenone made by the physician as part of his or her routine clinical practice and independently of the patient's inclusion in the study.
- Baseline serum potassium <5.0 mmol/L, determined prior to or at the time of inclusion in the study.
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- Signed informed consent.
- Prescription of finerenone within the authorized indications and in accordance with the prescribing information in force in the local market.
- No contraindications to the use of finerenone, in accordance with local marketing authorization and prescribing information in force.
Who cannot join
- Concomitant participation in an interventional clinical study involving interventions outside of routine clinical practice at any time during the follow-up period of the present study.
- Contra-indications according to the local label.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Profile, Treatment Patterns and Evolution of the Urinary Albumin-to-creatinine Ratio in Patients With Type 2 Diabetes and Chronic Kidney Disease Treated With Finerenone at the Primary Care of the IMSS: Observational, Prospective, Multicenter Study
The main purpose of this study is to learn how treatment with finerenone affects the urinary albumin-to-creatinine ratio (uACR), a marker of kidney health, over time in adults with type 2 diabetes and chronic kidney disease who are receiving care in primary care clinics as part of their usual medical care. The study will help researchers better understand how finerenone is used and how people respond to treatment in everyday primary care settings.
This is an observational study, which means the study does not decide or assign treatment. Participants will receive finerenone only if their primary care doctor has already decided to prescribe it as part of routine medical care. The doctor will determine the starting dose and make any dose changes based on the participant's individual needs.
All participants will be enrolled in a single study group and followed for up to 12 months after starting finerenone. Information collected during routine primary care visits may include kidney health measurements, laboratory test results, other medications, healthcare use, and any side effects experienced during treatment. Follow-up assessments are planned around Month 1, Month 3, Month 6, and Month 12. Information about adverse events will be collected until 30 days after the participant's last dose of finerenone. The study will not require additional treatment decisions beyond routine care and aims to understand how finerenone performs in real-world primary care practice.
- Being tested
- Finerenone
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
Follow clinical practice/administration.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone | Patients initiate finerenone according to routine clinical practice. Receives: Drug: Finerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the urinary albumin-to-creatinine ratio (uACR)
Assessed by change from baseline at 1, 3, 6 and 12 months after initiation of finerenone treatment.
Measured: Baseline and at months 1, 3, 6 and 12
Secondary outcomes (5)
Proportion of patients achieving a clinically relevant reduction in uACR
Defined as a relative decrease of at least 30% from baseline.
Measured: Baseline and at months 1, 3, 6 and 12
Magnitude of the relative change in uACR
Categorization of patients into response ranges <30%, 30% to <50%, and >=50% reduction from baseline.
Measured: Baseline and at months 1, 3, 6 and 12
Adherence and persistence to finerenone treatment
Adherence and persistence during follow-up under routine clinical practice conditions.
Measured: 12 months
Safety profile of finerenone
Occurrence of potentially treatment-related adverse events, serum potassium abnormalities, early eGFR changes, and related clinical actions.
Measured: Up to 12 months
Use of health resources
Consultations and laboratory studies according to information available in medical records.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start30 Oct 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841015
- Sponsor's protocol ID
- 23223
- Acronym
- FINE-IMSS-MX
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 he portal.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Profile, Treatment Patterns and Evolution of the Urinary Albumin-to-creatinine Ratio in Patients With Type 2 Diabetes and Chronic Kidney Disease Treated With Finerenone at the Primary Care of the IMSS: Observational, Prospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT07841015
- Acronym / sponsor ID
- FINE-IMSS-MX / 23223
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 25 Sep 2026 (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.
The main purpose of this study is to learn how treatment with finerenone affects the urinary albumin-to-creatinine ratio (uACR), a marker of kidney health, over time in adults with type 2 diabetes and chronic kidney disease who are receiving care in primary care clinics as part of their usual medical care. The study will help researchers better understand how finerenone is used and how people respond to treatment in everyday primary care settings.
This is an observational study, which means the study does not decide or assign treatment. Participants will receive finerenone only if their primary care doctor has already decided to prescribe it as part of routine medical care. The doctor will determine the starting dose and make any dose changes based on the participant's individual needs.
All participants will be enrolled in a single study group and followed for up to 12 months after starting finerenone. Information collected during routine primary care visits may include kidney health measurements, laboratory test results, other medications, healthcare use, and any side effects experienced during treatment. Follow-up assessments are planned around Month 1, Month 3, Month 6, and Month 12. Information about adverse events will be collected until 30 days after the participant's last dose of finerenone. The study will not require additional treatment decisions beyond routine care and aims to understand how finerenone performs in real-world primary care practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Finerenone | – | Drug: FinerenonePatients initiate finerenone according to routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged ≥18 years with T2D and CKD, of both sexes, treated in IMSS primary care units, who start treatment with finerenone as part of routine clinical practice.
Key inclusion criteria (9 listed)
- Adult participant - all genders (>=18 years old).
- Documented diagnosis of Type 2 diabetes (T2D), according to clinical criteria used in routine clinical practice.
- Documented diagnosis of Chronic Kidney Disease (CKD) in stages G2 to G3b, defined by an estimated glomerular filtration rate (Estimated Glomerular Filtration Rate [eGFR] >=30 and <90 mL/min/1.73 m^2 according to the information available in the clinical record).
- Baseline urinary albumin-to-creatinine ratio (uACR) value >=30 mg/g, documented at the time of inclusion in the study.
- Decision to initiate treatment with finerenone made by the physician as part of his or her routine clinical practice and independently of the patient's inclusion in the study.
Key exclusion criteria (2 listed)
- Concomitant participation in an interventional clinical study involving interventions outside of routine clinical practice at any time during the follow-up period of the present study.
- Contra-indications according to the local label.
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 |
|---|---|---|
| FinerenoneFollow clinical practice/administration. | Drug | Finerenone |
Primary outcome
Evolution of the urinary albumin-to-creatinine ratio (uACR)
Time frame: Baseline and at months 1, 3, 6 and 12
Assessed by change from baseline at 1, 3, 6 and 12 months after initiation of finerenone treatment.
5 secondary outcomes
Proportion of patients achieving a clinically relevant reduction in uACR
Time frame: Baseline and at months 1, 3, 6 and 12
Magnitude of the relative change in uACR
Time frame: Baseline and at months 1, 3, 6 and 12
Adherence and persistence to finerenone treatment
Time frame: 12 months
Safety profile of finerenone
Time frame: Up to 12 months
Use of health resources
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 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 he 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.
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 Type 2 Diabetes and Chronic Kidney Disease (CKD) Stages G2 to G3b, run by Bayer at 1 site in Mexico.
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 9 inclusion and 2 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: opening soon, as of the sponsor's last update on 21 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 Mexico. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact (0018888422937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the urinary albumin-to-creatinine ratio (uACR) (time frame: Baseline and at months 1, 3, 6 and 12). 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 21 Oct 2026.