Chronic Kidney DiseasePhase 4NCT05705271
A Study to Learn How Safe the Study Drug Finerenone is and How Well it Works in Indian People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 2 Diabetes Mellitus
A Phase 4 study testing Finerenone (Kerendia, BAY94-8862) in people with Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 17 sites in India.
Trial summary
Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 2 diabetes (T2D). In people with T2D, the body does not make enough of a hormone called insulin or does not use the insulin well enough. 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, BAY94-8862)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 17 sitesIndia
- Study dates
- 8 Feb 2023to 3 Jul 2025
- Phase
- Phase 4
- 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
Who may be able to join
- Participants capable of giving signed informed consent signed before any study-specific procedure and willing to comply with the study-related procedures.
- Diagnosis of chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
- Participants who are drug naïve for finerenone or patients who have been initiated on finerenone therapy within 4 weeks before signing the informed consent.
- Participants with serum potassium level ≤ 4.8 mmol/L at the time of Screening. If serum potassium level > 4.8 to 5.0 mmol/L, participants may be enrolled in the study, but additional potassium samples may be required; the potassium level needs to be confirmed during Screening. Participants with potassium level > 5.0 mmol/L are not allowed. The sample for potassium assessment for confirming eligibility shall be available before initiation of treatment with finerenone.
- Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Contraindications according to the local marketing authorization:
- Participants with eGFR < 25 mL/min/1.73 m^2 (calculated based on the CKD-EPI equation, using 2009 formula). eGFR can be reassessed once within 48 hours.
- Participants with severe hepatic impairment (Child-Pugh C).
- Participants with known hypersensitivity to the study treatment (active substance or excipients).
- Participants with Type 1 Diabetes.
- Participants taking concomitant medications that are strong CYP3A4 inhibitors.
Show all 12Show fewer
- Participants with Addison's disease.
- Glycated hemoglobin > 12% (17.5 mmol/L) at the Screening visit.
- Participants treated with another mineralocorticoid receptor antagonist (MRA), a renin inhibitor, potassium supplements, a potassium sparing diuretic, a potassium binder agent, or angiotensin receptor neprilysin inhibitor (ARNI) within 8 weeks prior to the Screening visit and during finerenone treatment.
- Participation in another interventional clinical trial within 30 days prior to the Screening visit and during finerenone treatment.
- Female participants who are pregnant or breast-feeding or plan to become pregnant or to breastfeed during the course of the study.
- Participants known for lack of compliance with clinic visits or prescribed medication.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
India17 sites
Kempegowda Institute of Medical Sciences Hospital & R C
Bangalore, Karnataka, 560004
All India Institute of Medical Sciences
Bhubaneswar, Odisha, 751019
Government Stanley Medical College and Hospital
Chennai, Tamil Nadu, 600001
M.V. Hospital & Research Centre 314/30
Chowk Lucknow, Uttar Pradesh, 226003
Accord Superspeciality Hospital
Faridabad, Haryana, 121002
Jawaharlal Institute Of Postgraduate Medical Education and R
Gorimedu, Puducherry, 605006
Nizam's Institute of Medical Sciences (NIMS)
Hyderabad, 500082
Bhate Hospital
Karnataka, Belagavi, 590002
Medica Superspecialty Hospital
Kolkata, West Bengal, 700099
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Lucknow, Uttar Pradesh, 226 014
Global Hospital-Super Speciality And Transplant Centre
Mumbai, Maharashtra, 400012
Lancelot Medical Centre
Mumbai, Maharashtra, 400092
Dr Balabhai Nanavati Hospital
Mumbai, Maharashtra,, Maharashtra, 400056
Muljibhai Patel Urological Hospital (MPUH) (Kidney Hospital)
Nadiād, Gujarat, 387001
PSRI Institute of Renal Sciences
New Delhi, National Capital Territory of Delhi, 110017
Vardhman Mahavir Medical College & Safdarjung Hospital (VMMC-SJH)
New Delhi, National Capital Territory of Delhi, 110029
Christian Medical College
Vellore, Kerala, 632004
About this study
Official title: A Prospective, Interventional, Multicenter, Phase IV, Open-label, Single Arm Study to Assess the Safety and Effectiveness of Finerenone in Participants From India With Chronic Kidney Disease Associated With Type 2 Diabetes.
Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 2 diabetes (T2D).
In people with T2D, the body does not make enough of a hormone called insulin or does not use the insulin well enough. Insulin's role is to regulate the amount of glucose (sugar) in the blood. Too much blood sugar can cause damage to the kidneys over time. Consequently, CKD can happen as one of the complications of T2D.
Read more
The study treatment finerenone works by blocking a group of proteins, called mineralocorticoid receptor. An increased stimulation of the mineralocorticoid receptor is known to trigger injury and inflammation in the kidney and is therefore thought to play a role in CKD.
Finerenone is already available in several countries for doctors to prescribe to people with CKD and T2D. In addition, it was recently approved in India with a request to specifically gather information on finerenone therapy in Indians.
The main purpose of this study is to learn how safe finerenone is in Indian people with CKD and T2D. For this, the researchers will count the number of participants who have:
- medical problems after taking finerenone
- abnormal high levels of potassium in the blood (called hyperkalemia).
Researcher will also count the number of participants in whom hyperkalemia:
- leads to stop of finerenone treatment
- requires treatment to filter wastes and water from the blood
- leads to a hospital stay.
Doctors keep track of all medical problems that happen in studies, even if they do not think the medical problems might be related to the study treatments.
In addition, the study team will collect more data about how well finerenone works in Indian people with CKD and T2D under real world setting. Working well means that the treatment can prevent the following from happening:
- reduced kidney function over a period of at least 4 weeks
- death from renal problems
- death due to conditions affecting the heart and blood circulation
- heart attack (blocked blood flow to the heart)
- hospital stay due to a condition which occurs when the heart does not pump blood as well as it should
- changes of the albumin and creatinine levels in urine.
The participants will be in the study for approximately 20 months. They will take the study treatment once daily as a tablet by mouth for 18 months. In the study, 9 visits to the study site are planned.
During the study, the study team will:
- take blood and urine samples
- do physical examinations
- check the participants' overall health
- do pregnancy tests
- examine heart health using electrocardiogram ECG
- check vital signs.
About 30 days after the participants take their last treatment, the study doctors and their team will check worsening of reported underlying diseases:
- damage to the blood vessels in the tissue of the retina at the back of the eye, as a result of diabetes mellitus
- a long-term condition where the heart does not pump blood as well as it should with symptoms such as shortness of breath, tiredness and ankle swelling
- heart attack (blocked blood flow to the heart)
- death due to conditions affecting the heart and blood circulation or
- hospital stay.
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Being tested
- Finerenone (Kerendia, BAY94-8862)
- 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, BAY94-8862)Drug
Film-coated tablet, oral administration, once daily (OD), dosage based on the eGFR and serum potassium thresholds
| Study group | Role | What they receive |
|---|---|---|
| Finerenone | Experimental | Participants will receive study treatment for 18 months ± 7 days. Receives: Drug: Finerenone (Kerendia, BAY94-8862) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Measured: From the first finerenone treatment date up to 30 days after the last treatment date
Number of participants with hyperkalemia events
including hyperkalemia (serum potassium > 5.5 mmol/L), severe hyperkalemia (serum potassium > 6.0 mmol/L), hyperkalemia leading to study drug discontinuation, hyperkalemia leading to dialysis and hyperkalemia leading to hospitalization
Measured: Up to 19 months
Secondary outcomes (3)
Time to the first occurrence of the composite of kidney failure, a sustained decrease of at least 40% in the estimated glomerular filtration Rate (eGFR) from baseline over a period of at least 4 weeks, or death from renal cause
Measured: Up to 19 months
Time to the first occurrence of composite of cardiovascular (CV) death, nonfatal myocardial infarction, or hospitalization for heart failure (HF)
Measured: Up to 19 months
Change in urine albumin-to-creatinine ratio (UACR) from baseline to 4 months
Measured: From baseline to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start8 Feb 2023
- Primary completion3 Jul 2025
- Study completion3 Jul 2025
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705271
- Sponsor's protocol ID
- 22224
- Status last verified
- Jul 2025
- First submitted
- 20 Jan 2023
- Last updated
- 9 Jul 2025
- Results posted
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Interventional, Multicenter, Phase IV, Open-label, Single Arm Study to Assess the Safety and Effectiveness of Finerenone in Participants From India With Chronic Kidney Disease Associated With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT05705271
- Acronym / sponsor ID
- 22224
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 30 Jan 2023 (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.
Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 2 diabetes (T2D).
In people with T2D, the body does not make enough of a hormone called insulin or does not use the insulin well enough. Insulin's role is to regulate the amount of glucose (sugar) in the blood. Too much blood sugar can cause damage to the kidneys over time. Consequently, CKD can happen as one of the complications of T2D.
The study treatment finerenone works by blocking a group of proteins, called mineralocorticoid receptor. An increased stimulation of the mineralocorticoid receptor is known to trigger injury and inflammation in the kidney and is therefore thought to play a role in CKD.
Finerenone is already available in several countries for doctors to prescribe to people with CKD and T2D. In addition, it was recently approved in India with a request to specifically gather information on finerenone therapy in Indians.
The main purpose of this study is to learn how safe finerenone is in Indian people with CKD and T2D. For this, the researchers will count the number of participants who have:
- medical problems after taking finerenone
- abnormal high levels of potassium in the blood (called hyperkalemia).
Researcher will also count the number of participants in whom hyperkalemia:
- leads to stop of finerenone treatment
- requires treatment to filter wastes and water from the blood
- leads to a hospital stay.
Doctors keep track of all medical problems that happen in studies, even if they do not think the medical problems might be related to the study treatments.
In addition, the study team will collect more data about how well finerenone works in Indian people with CKD and T2D under real world setting. Working well means that the treatment can prevent the following from happening:
- reduced kidney function over a period of at least 4 weeks
- death from renal problems
- death due to conditions affecting the heart and blood circulation
- heart attack (blocked blood flow to the heart)
- hospital stay due to a condition which occurs when the heart does not pump blood as well as it should
- changes of the albumin and creatinine levels in urine.
The participants will be in the study for approximately 20 months. They will take the study treatment once daily as a tablet by mouth for 18 months. In the study, 9 visits to the study site are planned.
During the study, the study team will:
- take blood and urine samples
- do physical examinations
- check the participants' overall health
- do pregnancy tests
- examine heart health using electrocardiogram ECG
- check vital signs.
About 30 days after the participants take their last treatment, the study doctors and their team will check worsening of reported underlying diseases:
- damage to the blood vessels in the tissue of the retina at the back of the eye, as a result of diabetes mellitus
- a long-term condition where the heart does not pump blood as well as it should with symptoms such as shortness of breath, tiredness and ankle swelling
- heart attack (blocked blood flow to the heart)
- death due to conditions affecting the heart and blood circulation or
- hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Finerenone | Experimental | Drug: Finerenone (Kerendia, BAY94-8862)Participants will receive study treatment for 18 months ± 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants capable of giving signed informed consent signed before any study-specific procedure and willing to comply with the study-related procedures.
- Diagnosis of chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
- Participants who are drug naïve for finerenone or patients who have been initiated on finerenone therapy within 4 weeks before signing the informed consent.
- Participants with serum potassium level ≤ 4.8 mmol/L at the time of Screening. If serum potassium level > 4.8 to 5.0 mmol/L, participants may be enrolled in the study, but additional potassium samples may be required; the potassium level needs to be confirmed during Screening. Participants with potassium level > 5.0 mmol/L are not allowed. The sample for potassium assessment for confirming eligibility shall be available before initiation of treatment with finerenone.
- Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Key exclusion criteria (12 listed)
- Contraindications according to the local marketing authorization:
- Glycated hemoglobin > 12% (17.5 mmol/L) at the Screening visit.
- Participants treated with another mineralocorticoid receptor antagonist (MRA), a renin inhibitor, potassium supplements, a potassium sparing diuretic, a potassium binder agent, or angiotensin receptor neprilysin inhibitor (ARNI) within 8 weeks prior to the Screening visit and during finerenone treatment.
- Participation in another interventional clinical trial within 30 days prior to the Screening visit and during finerenone treatment.
- Female participants who are pregnant or breast-feeding or plan to become pregnant or to breastfeed during the course of the study.
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, BAY94-8862)Film-coated tablet, oral administration, once daily (OD), dosage based on the eGFR and serum potassium thresholds | Drug | Finerenone |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Time frame: From the first finerenone treatment date up to 30 days after the last treatment date
Number of participants with hyperkalemia events
Time frame: Up to 19 months
including hyperkalemia (serum potassium > 5.5 mmol/L), severe hyperkalemia (serum potassium > 6.0 mmol/L), hyperkalemia leading to study drug discontinuation, hyperkalemia leading to dialysis and hyperkalemia leading to hospitalization
3 secondary outcomes
Time to the first occurrence of the composite of kidney failure, a sustained decrease of at least 40% in the estimated glomerular filtration Rate (eGFR) from baseline over a period of at least 4 weeks, or death from renal cause
Time frame: Up to 19 months
Time to the first occurrence of composite of cardiovascular (CV) death, nonfatal myocardial infarction, or hospitalization for heart failure (HF)
Time frame: Up to 19 months
Change in urine albumin-to-creatinine ratio (UACR) from baseline to 4 months
Time frame: From baseline to 4 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 9 Jul 2025.
- 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.
Related trials for Chronic Kidney Disease
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
RecruitingObservational study
The KidneyCARE (Community Access to Research Equity) Study
Chronic Kidney Disease, Dialysis
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
RecruitingObservational study
Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
Gastric Antral Vascular Ectasia, Cirrhosis
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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Finerenone (Kerendia, BAY94-8862) in people with Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 17 sites 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 5 inclusion and 12 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 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) (time frame: From the first finerenone treatment date up to 30 days after the last treatment date). The study lists 2 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 9 Jul 2025.