ClinicalTrials.gg
Not yet recruitingNCT07841015FINE-IMSS-MXUpdated Oct 21, 2026

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 in Type 2 Diabetes and Chronic Kidney Disease (CKD) Stages G2 to G3b, sponsored by Bayer. Not yet recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Bayer · Observational

Updated Oct 21, 2026Start date movedPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 37 studies in Diabetes Mellitus, Type 2 by Bayer — 3 open to participants now, 6 under way, none of them phase 3. Diabetes Mellitus, Type 2 · Bayer.

Planned enrollment
17th of 25
800 · median 4,564
Started
2026
with 1 other
Observational
25 of 37
3 open now
Registered
37th of 37
by date

Among the 37 studies in Diabetes Mellitus, Type 2 by Bayer, this one is the 17th largest by planned enrollment of the 25 observational ones that give a count, is one of 2 that started in 2026, is one of 25 observational ones, and was the 37th registered.

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 800 is above the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Open to participants now

3 of the 37 studies in Diabetes Mellitus, Type 2 by Bayer are open now, in 6 countries. Each count lists the studies.

All 3 open studies →

Who these studies take

Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 37 studies in Diabetes Mellitus, Type 2 by Bayer, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Type 2 Diabetes
  • Chronic Kidney Disease (CKD) Stages G2 to G3b
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 (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.
  • Signed .
  • Prescription of finerenone within the authorized indications and in accordance with the prescribing information in force in the local market.
  • No to the use of finerenone, in accordance with local marketing authorization and prescribing information in force.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • according to the local label.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No

Groups and cohorts

  • Finerenone

    Patients initiate finerenone according to routine clinical practice.

    Drug: Finerenone

Interventions

  • Follow clinical practice/administration.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and at months 1, 3, 6 and 12

Secondary outcomes

  1. Proportion of patients achieving a clinically relevant reduction in uACR

    Defined as a relative decrease of at least 30% from baseline.

    Time frame: Baseline and at months 1, 3, 6 and 12

  2. Magnitude of the relative change in uACR

    Categorization of patients into response ranges \<30%, 30% to \<50%, and \>=50% reduction from baseline.

    Time frame: Baseline and at months 1, 3, 6 and 12

  3. Adherence and persistence to finerenone treatment

    Adherence and persistence during follow-up under routine clinical practice conditions.

    Time frame: 12 months

  4. Safety profile of finerenone

    Occurrence of potentially treatment-related adverse events, serum potassium abnormalities, early eGFR changes, and related clinical actions.

    Time frame: Up to 12 months

  5. Use of health resources

    Consultations and laboratory studies according to information available in medical records.

    Time frame: Up to 12 months

07

Study locations

1 site
  • Many locations
    Multiple Locations, Mexico
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jan 2028, 15 months later.

Of 170 industry-sponsored observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 44. This study's planned 15 months is below that.

Counting every sponsor, half of 602 studies reached it within 32 months; a quarter within 17 and three quarters within 62.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 21, 2026: start Sep 2026 → Oct 2026, primary completion Dec 2027 → Jan 2028 and completion Dec 2027 → Jan 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2026
First posted
Sep 25, 2026
StartEst.
Oct 30, 2026was Sep 2026
Primary completionEst.
Jan 31, 2028was Dec 2027
CompletionEst.
Jan 31, 2028was Dec 2027
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 30, 2026→Oct 30, 2026
Oct 21, 2026
Primary completion
Dec 31, 2027→Jan 31, 2028
Oct 21, 2026
Study completion
Dec 31, 2027→Jan 31, 2028
Oct 21, 2026
Registered
First appeared on the registry
Sep 25, 2026
Show all 2 updates
  1. Oct 21, 2026
    Start date Sep 30, 2026→Oct 30, 2026
    Primary completion Dec 31, 2027→Jan 31, 2028
    Study completion Dec 31, 2027→Jan 31, 2028
    + 3 other changes: identifiers, verification date and data sharing statement
  2. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07841015
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Sep 25, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Jan 31, 2028 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
Oct 21, 2026

Study contacts

Bayer Clinical Trials Contact
Contact
clinical-trials-contact@bayer.com
0018888422937

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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