Chronic Kidney DiseaseIN-REALITYNCT06763146
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
An observational study of Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 1 site in India.
Trial summary
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. 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
- 1,200 participants
- Where
- 1 siteIndia
- Study dates
- 22 Sep 2025to 31 Oct 2026
- 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: Patients with a diagnosis of CKD associated with T2D who are initiated on finerenone under routine clinical management.
Who may be able to join
- Patients from India (Indian ethnicity) diagnosed with CKD and T2D prior to initiating finerenone (per the standard diagnostic criteria) and initiated on finerenone per approved label.
- Patient was prescribed finerenone for the first time (drug naïve) for the management of CKD and T2D between 1st August 2022 and 30th April 2024.
- Age 18 years or older at the time of finerenone initiation.
Who cannot join
- eGFR <25 mL/min/1.73 m^2
- Serum potassium >5.0 mmol/L
- Type 1 diabetes is recorded in the patient record
- Contraindications according to the local marketing authorization - Patient data will be excluded if below information is identified in the patient record at any point from index date to the end of observation period:
- - Pregnancy.
- - Lactation.
Show all 9Show fewer
- - Patient taking concomitant medications that are strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin and nefazodone).
- - Addison's disease.
- Patient was a part of an interventional clinical study between 1st August 2022 and 30th Nov 2024.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Experience With Finerenone Treatment in Patients From India With Chronic Kidney Disease and Type 2 Diabetes-Retrospective Data Analysis
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.
Read the detailed description
This is an observational study in which data already collected from people with chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D) are studied.
T2D is a condition in which glucose levels rise in the blood. It is one of the common causes of CKD and can lead to kidney failure. CKD is a long-term condition in which the kidneys' ability to work properly gradually decreases over time.
The study drug, finerenone, is already approved for doctors to prescribe to people with CKD and T2D. It blocks the activity of a protein involved in worsening kidney function.
People with CKD and T2D are already receiving treatment with finerenone based on the results of previous studies. These studies, however, did not include Indian participants.
To better understand the impact of finerenone on CKD and T2D, more knowledge is needed about how well it works in the Indian population.
The main purpose of the study is to learn more about how well finerenone works and how safe it is in Indian people with CKD and T2D. To do this, researchers will check:
- participants' characteristics including age, sex, height and weight, and signs and symptoms of the disease
- other conditions the participants may have along with CKD and T2D, additional medicines they have taken with finerenone, and different treatment patterns in Indian participants.
The different treatment pattern for finerenone includes:
- specialty of the doctor who prescribed finerenone
- the date of starting finerenone
- whether participants were still taking finerenone at each follow-up visit
- the date and reason for stopping finerenone early
- the dose of finerenone the participants took and how often they took it
- changes in the dosage either with a low dose or high dose compared with the previous firenone dose
- after starting finerenone treatment: reseachers may ask to continue treatment with finerenone, or may suggest adding other treatments like SGLT2 inhibitors or potassium binders, or stop finerenone treatment
- after stopping finerenone treatment: researchers may start other treatments, like SGLT2 inhibitors, RAAS inhibitors, or potassium binders or other therapy
Researchers will only look at the medical records from participants in India. Data collected will be from August 2022 to April 2024.
Researchers will track participants' data in India and will follow them until the end of the study period till Nov 2024, last visit date of the participant, the participant discontinues treatment with finerenone, death, kidney failure, or cancer of the kidney.
In this study, only available data from routine care in India 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)
- 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
Retrospective cohort analysis using the investigator or a delegate at the study site collects secondary/historic data of finerenone usage (patient demographic and clinical characteristics, diagnosis-related, treatment-related, and laboratory data) from clinic specific medical records.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone (Kerendia, BAY948862) | Patients with CKD and T2D from India who initiate on finerenone per approved label. 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 specialty of prescribing physician
Measured: Retrospective data analysis from 2022 to 2024
Date of finerenone initiation
Measured: Retrospective data analysis from 2022 to 2024
If patient was receiving finerenone at the time of each follow-up visit (Yes/No)
Measured: Retrospective data analysis from 2022 to 2024
Date of discontinuation of finerenone
Measured: Retrospective data analysis from 2022 to 2024
Reason for discontinuation of finerenone
Measured: Retrospective data analysis from 2022 to 2024
Dose of finerenone treatment
Measured: Retrospective data analysis from 2022 to 2024
Frequency of finerenone treatment
Measured: Retrospective data analysis from 2022 to 2024
The number of patients who initiated finerenone with a 10-mg dose and 20-mg dose
Measured: Retrospective data analysis from 2022 to 2024
The proportion of patients who initiated finerenone with a 10-mg dose and have up-titrated to a 20-mg dose
Measured: Retrospective data analysis from 2022 to 2024
The proportion of patients who initiated finerenone with a 20-mg dose and have down-titrated to a 10-mg dose
Measured: Retrospective data analysis from 2022 to 2024
Actions taken after finerenone introduction
Actions include continue treatment, addition of second therapy like SGLT2is, potassium binders, discontinue treatment
Measured: Retrospective data analysis from 2022 to 2024
Actions taken after stop finerenone prescription
Actions include initiate alternate therapy like Sodium-glucose transport protein-2 inhibitor (SGLT2is), RAASis or potassium binders, other
Measured: Retrospective data analysis from 2022 to 2024
Secondary outcomes (7)
UACR (mg/g) before and after initiating finerenone
UACR: Urine Albumin to Creatinine Ratio
Measured: Retrospective data analysis from Aug 2022 to Apr 2024
eGFR before and after initiating finerenone
eGFR: Estimated glomerular filtration rate
Measured: Retrospective data analysis from Aug 2022 to Apr 2024
Serum potassium (mmol/L) before and after initiating finerenone
Measured: Retrospective data analysis from Aug 2022 to Apr 2024
Change in UACR after initiating finerenone vs month 1, month 4 and end of study
Measured: Retrospective data analysis from 2022 to 2024
Change in serum potassium after initiating finerenone vs month 1, month 4 and end of study
Measured: Retrospective data analysis from Aug 2022 to Apr 2024
Change in Serum creatinine/eGFR after initiating finerenone vs month 1, month 4 and end of study
Measured: Retrospective data analysis from Aug 2022 to Apr 2024
Frequency of events like hospitalization and dialysis due to hyperkalemia
Measured: Retrospective data analysis from Aug 2022 to Apr 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start22 Sep 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763146
- Sponsor's protocol ID
- 22549
- Acronym
- IN-REALITY
- Status last verified
- Oct 2026
- First submitted
- 2 Jan 2025
- Last updated
- 14 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Experience With Finerenone Treatment in Patients From India With Chronic Kidney Disease and Type 2 Diabetes-Retrospective Data Analysis
- ClinicalTrials.gov ID
- NCT06763146
- Acronym / sponsor ID
- IN-REALITY / 22549
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Keywords
- CKD, T2DM
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 8 Jan 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.
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.
Detailed description
This is an observational study in which data already collected from people with chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D) are studied.
T2D is a condition in which glucose levels rise in the blood. It is one of the common causes of CKD and can lead to kidney failure. CKD is a long-term condition in which the kidneys' ability to work properly gradually decreases over time.
The study drug, finerenone, is already approved for doctors to prescribe to people with CKD and T2D. It blocks the activity of a protein involved in worsening kidney function.
People with CKD and T2D are already receiving treatment with finerenone based on the results of previous studies. These studies, however, did not include Indian participants.
To better understand the impact of finerenone on CKD and T2D, more knowledge is needed about how well it works in the Indian population.
The main purpose of the study is to learn more about how well finerenone works and how safe it is in Indian people with CKD and T2D. To do this, researchers will check:
- participants' characteristics including age, sex, height and weight, and signs and symptoms of the disease
- other conditions the participants may have along with CKD and T2D, additional medicines they have taken with finerenone, and different treatment patterns in Indian participants.
The different treatment pattern for finerenone includes:
- specialty of the doctor who prescribed finerenone
- the date of starting finerenone
- whether participants were still taking finerenone at each follow-up visit
- the date and reason for stopping finerenone early
- the dose of finerenone the participants took and how often they took it
- changes in the dosage either with a low dose or high dose compared with the previous firenone dose
- after starting finerenone treatment: reseachers may ask to continue treatment with finerenone, or may suggest adding other treatments like SGLT2 inhibitors or potassium binders, or stop finerenone treatment
- after stopping finerenone treatment: researchers may start other treatments, like SGLT2 inhibitors, RAAS inhibitors, or potassium binders or other therapy
Researchers will only look at the medical records from participants in India. Data collected will be from August 2022 to April 2024.
Researchers will track participants' data in India and will follow them until the end of the study period till Nov 2024, last visit date of the participant, the participant discontinues treatment with finerenone, death, kidney failure, or cancer of the kidney.
In this study, only available data from routine care in India are collected. No visits or tests are required as part of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Finerenone (Kerendia, BAY948862) | – | Drug: Finerenone (Kerendia, BAY948862)Patients with CKD and T2D from India who initiate on finerenone per approved label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of CKD associated with T2D who are initiated on finerenone under routine clinical management.
Key inclusion criteria (3 listed)
- Patients from India (Indian ethnicity) diagnosed with CKD and T2D prior to initiating finerenone (per the standard diagnostic criteria) and initiated on finerenone per approved label.
- Patient was prescribed finerenone for the first time (drug naïve) for the management of CKD and T2D between 1st August 2022 and 30th April 2024.
- Age 18 years or older at the time of finerenone initiation.
Key exclusion criteria (9 listed)
- eGFR <25 mL/min/1.73 m^2
- Serum potassium >5.0 mmol/L
- Type 1 diabetes is recorded in the patient record
- Contraindications according to the local marketing authorization - Patient data will be excluded if below information is identified in the patient record at any point from index date to the end of observation period:
- - Pregnancy.
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 investigator or a delegate at the study site collects secondary/historic data of finerenone usage (patient demographic and clinical characteristics, diagnosis-related, treatment-related, and laboratory data) from clinic specific medical records. | Drug | Finerenone (Kerendia, BAY948862) |
Primary outcome
Descriptive summary of specialty of prescribing physician
Time frame: Retrospective data analysis from 2022 to 2024
Date of finerenone initiation
Time frame: Retrospective data analysis from 2022 to 2024
If patient was receiving finerenone at the time of each follow-up visit (Yes/No)
Time frame: Retrospective data analysis from 2022 to 2024
Date of discontinuation of finerenone
Time frame: Retrospective data analysis from 2022 to 2024
Reason for discontinuation of finerenone
Time frame: Retrospective data analysis from 2022 to 2024
Dose of finerenone treatment
Time frame: Retrospective data analysis from 2022 to 2024
Frequency of finerenone treatment
Time frame: Retrospective data analysis from 2022 to 2024
The number of patients who initiated finerenone with a 10-mg dose and 20-mg dose
Time frame: Retrospective data analysis from 2022 to 2024
The proportion of patients who initiated finerenone with a 10-mg dose and have up-titrated to a 20-mg dose
Time frame: Retrospective data analysis from 2022 to 2024
The proportion of patients who initiated finerenone with a 20-mg dose and have down-titrated to a 10-mg dose
Time frame: Retrospective data analysis from 2022 to 2024
Actions taken after finerenone introduction
Time frame: Retrospective data analysis from 2022 to 2024
Actions include continue treatment, addition of second therapy like SGLT2is, potassium binders, discontinue treatment
Actions taken after stop finerenone prescription
Time frame: Retrospective data analysis from 2022 to 2024
Actions include initiate alternate therapy like Sodium-glucose transport protein-2 inhibitor (SGLT2is), RAASis or potassium binders, other
7 secondary outcomes
UACR (mg/g) before and after initiating finerenone
Time frame: Retrospective data analysis from Aug 2022 to Apr 2024
eGFR before and after initiating finerenone
Time frame: Retrospective data analysis from Aug 2022 to Apr 2024
Serum potassium (mmol/L) before and after initiating finerenone
Time frame: Retrospective data analysis from Aug 2022 to Apr 2024
Change in UACR after initiating finerenone vs month 1, month 4 and end of study
Time frame: Retrospective data analysis from 2022 to 2024
Change in serum potassium after initiating finerenone vs month 1, month 4 and end of study
Time frame: Retrospective data analysis from Aug 2022 to Apr 2024
Change in Serum creatinine/eGFR after initiating finerenone vs month 1, month 4 and end of study
Time frame: Retrospective data analysis from Aug 2022 to Apr 2024
Frequency of events like hospitalization and dialysis due to hyperkalemia
Time frame: Retrospective data analysis from Aug 2022 to Apr 2024
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 14 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 India.
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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 14 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 India. 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?
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 specialty of prescribing physician (time frame: Retrospective data analysis from 2022 to 2024). The study lists 12 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 Oct 2026.