Diabetic Kidney Disease (DKD)NCT07326631
Finerenone for Cardiorenal Protection in Diabetic CKD: Impact on Renal Function Decline and Heart Failure
A study testing Finerenone in people with Diabetic Kidney Disease (DKD) and Heart Failure, run by College of Physicians and Surgeons Pakistan.
Trial summary
To assess the effect of Finerinone on slowing renal function decline and improving cardiovascular outcomes, particularly heart failure risk, in patients with diabetic CKD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Kidney Disease (DKD), Heart Failure
- What is being tested?
- Finerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jul 2026
- Phase
- Interventional
- 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
Who may be able to join
- Adults aged ≥18 years.
- Diagnosed cases of type 2 diabetes mellitus.
- Chronic kidney disease with eGFR 25-90 mL/min/1.73m² and/or UACR ≥30 mg/g.
- On stable ACE inhibitor or ARB therapy for at least 4 weeks.
- Serum potassium ≤4.8 mmol/L.
- Provided written informed consent.
Who cannot join
- Symptomatic heart failure (NYHA class II-IV).
- eGFR <25 mL/min/1.73m² or on maintenance dialysis.
- Known non-diabetic kidney disease.
- Recent major cardiovascular event (within 30 days).
- Serum potassium >4.8 mmol/L or history of severe hyperkalaemia.
- Contraindication or hypersensitivity to finerenone.
- Pregnancy or lactation.
- Any condition limiting compliance or follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To assess the effect of Finerinone on slowing renal function decline and improving cardiovascular outcomes, particularly heart failure risk, in patients with diabetic CKD.
- Conditions
- Diabetic Kidney Disease (DKD), Heart Failure
- Being tested
- Finerenone
- Medical subject headings
- Diabetic Nephropathies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
To assess the effect of Finerinone on slowing renal function decline and improving cardiovascular outcomes, particularly heart failure risk, in patients with diabetic CKD.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone Group | Experimental | Finerenone Drug Receives: Drug: Finerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Renal Function Decline post finerinone therapy
Progressive worsening of kidney function is defined as a sustained ≥40% reduction in eGFR from baseline, progression to kidney failure (ESKD), or renal death.
Measured: From enrollment to the end of treatment at 06 months
Number of Participants with Heart Failure (HF) Event post finerinone therapy
Defined as hospitalization for new or worsening heart failure, confirmed by clinical evidence of fluid overload, raised BNP levels and the requirement for intravenous therapy or hemodynamic support.
Measured: 6 month
eGFR Measurement
Estimated glomerular filtration rate calculated using the CKD-EPI formula, standardized for body surface area (mL/min/1.73 m²).
Measured: 06 months
Number of Participants with Albuminuria
Measured as urinary albumin-to-creatinine ratio (UACR), with categories of moderately increased (30-300 mg/g) and severely increased (>300 mg/g) albuminuria, per KDIGO classification used in the trial protocols.
Measured: 06 months
Number of Participants with Hyperkalaemia post treatment
Defined as a serum potassium level >5.5 mmol/L, which served as a safety threshold for dose adjustment or discontinuation in the parent trial data.
Measured: 06 months
Number of Participants with Cardiovascular (CV) Event post treatment with finerinone therapy
Includes CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure (HHF) - forming the composite cardiovascular outcome measure in the finerenone studies.
Measured: 06 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney Disease (DKD)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- College of Physicians and Surgeons Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Awais Danish, Nishtar Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326631
- Sponsor's protocol ID
- 22126
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finerenone for Cardiorenal Protection in Diabetic CKD: Impact on Renal Function Decline and Heart Failure
- ClinicalTrials.gov ID
- NCT07326631
- Acronym / sponsor ID
- 22126
- Conditions
- Diabetic Kidney Disease (DKD), Heart Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- College of Physicians and Surgeons PakistanUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 8 Jan 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.
To assess the effect of Finerinone on slowing renal function decline and improving cardiovascular outcomes, particularly heart failure risk, in patients with diabetic CKD.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Finerenone Group | Experimental | Drug: FinerenoneFinerenone Drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged ≥18 years.
- Diagnosed cases of type 2 diabetes mellitus.
- Chronic kidney disease with eGFR 25-90 mL/min/1.73m² and/or UACR ≥30 mg/g.
- On stable ACE inhibitor or ARB therapy for at least 4 weeks.
- Serum potassium ≤4.8 mmol/L.
Key exclusion criteria (8 listed)
- Symptomatic heart failure (NYHA class II-IV).
- eGFR <25 mL/min/1.73m² or on maintenance dialysis.
- Known non-diabetic kidney disease.
- Recent major cardiovascular event (within 30 days).
- Serum potassium >4.8 mmol/L or history of severe hyperkalaemia.
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 |
|---|---|---|
| FinerenoneTo assess the effect of Finerinone on slowing renal function decline and improving cardiovascular outcomes, particularly heart failure risk, in patients with diabetic CKD. | Drug | Finerenone Group |
Primary outcome
Number of Participants with Renal Function Decline post finerinone therapy
Time frame: From enrollment to the end of treatment at 06 months
Progressive worsening of kidney function is defined as a sustained ≥40% reduction in eGFR from baseline, progression to kidney failure (ESKD), or renal death.
Number of Participants with Heart Failure (HF) Event post finerinone therapy
Time frame: 6 month
Defined as hospitalization for new or worsening heart failure, confirmed by clinical evidence of fluid overload, raised BNP levels and the requirement for intravenous therapy or hemodynamic support.
eGFR Measurement
Time frame: 06 months
Estimated glomerular filtration rate calculated using the CKD-EPI formula, standardized for body surface area (mL/min/1.73 m²).
Number of Participants with Albuminuria
Time frame: 06 months
Measured as urinary albumin-to-creatinine ratio (UACR), with categories of moderately increased (30-300 mg/g) and severely increased (>300 mg/g) albuminuria, per KDIGO classification used in the trial protocols.
Number of Participants with Hyperkalaemia post treatment
Time frame: 06 months
Defined as a serum potassium level >5.5 mmol/L, which served as a safety threshold for dose adjustment or discontinuation in the parent trial data.
Number of Participants with Cardiovascular (CV) Event post treatment with finerinone therapy
Time frame: 06 months
Includes CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure (HHF) - forming the composite cardiovascular outcome measure in the finerenone studies.
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 8 Jan 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Finerenone in people with Diabetic Kidney Disease (DKD) and Heart Failure, run by College of Physicians and Surgeons Pakistan.
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 6 inclusion and 8 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 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Muhammad Awais Danish, FCPS (Internal Medicine) (923037589797, raoawaisdanish@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Renal Function Decline post finerinone therapy (time frame: From enrollment to the end of treatment at 06 months). The study lists 6 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 8 Jan 2026.