A Phase 4 interventional study of Finerenone (BAY 94-8862) and Placebo in Albuminuria, Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Diseases, sponsored by First Affiliated Hospital of Zhejiang University. Not yet recruiting at 13 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by First Affiliated Hospital of Zhejiang University · Phase 4, Interventional, and Treatment
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of finerenone, a nonsteroidal mineralocorticoid receptor antagonist, for the early regression of albuminuria in adults with type 2 diabetes mellitus and chronic kidney disease (eGFR >= 30 mL/min/1.73 m\^2 and UACR 30-2000 mg/g) who are already receiving a maximum tolerated dose of an ACE inhibitor or ARB. A total of 148 participants are randomized 1:1, stratified by baseline UACR (\<300 vs >=300 mg/g), to oral finerenone (10 or 20 mg once daily, titrated by serum potassium and eGFR) or matching placebo, on top of standard background therapy, for 180 days, followed by a 30-day off-treatment follow-up. Albuminuria regression is defined as both an improvement in Kidney Disease: Improving Global Outcomes albuminuria category, from A3 to A2 or A1, or from A2 to A1, and a more than 30% reduction in urinary albumin-to-creatinine ratio from baseline. The outcome will be reported as the percentage of participants meeting this definition at Day 180.
Background and rationale: Finerenone is an oral, highly selective nonsteroidal mineralocorticoid receptor antagonist approved in China for the treatment of chronic kidney disease associated with type 2 diabetes (with albuminuria). In the phase III FIDELIO-DKD and FIGARO-DKD trials, finerenone added to a maximum tolerated dose of a renin-angiotensin system inhibitor significantly and durably reduced the urine albumin-to-creatinine ratio (UACR) and lowered the risk of kidney and cardiovascular events, with a manageable hyperkalemia risk. A meaningful reduction in albuminuria is an established early surrogate for slowing CKD progression and reducing cardiovascular risk. This study evaluates whether finerenone can achieve early regression of albuminuria in patients with type 2 diabetes and CKD.
Design: This is a multicenter, randomized, double-blind, placebo-controlled trial conducted at up to 12 sites in China. A planned 148 participants are allocated 1:1 to finerenone or matching placebo using central, block randomization (interactive response technology), stratified by baseline UACR (\<300 vs >=300 mg/g). Participants and investigators are blinded; placebo tablets are identical in appearance to finerenone, and intervention-period UACR samples are assayed centrally after study completion to preserve blinding.
Population: Eligible participants are adults with type 2 diabetes and CKD (eGFR >= 30 mL/min/1.73 m\^2 and UACR 30-2000 mg/g) who have received a maximum tolerated dose of an ACE inhibitor or ARB for at least 90 days and have serum potassium \<= 5.0 mmol/L.
Intervention and dose titration: The starting dose is determined by screening eGFR: 10 mg once daily for 30 \<= eGFR \< 60 mL/min/1.73 m\^2, or 20 mg once daily for eGFR >= 60 mL/min/1.73 m\^2. The dose is up-titrated to 20 mg, maintained, interrupted, or down-titrated to 10 mg based on serum potassium and eGFR at scheduled and, if needed, unscheduled safety visits. Treatment continues for 180 days.
Visit schedule: a screening period (Day -30 to -1; V1); a treatment period ; and an off-treatment follow-up at Day 210 +/- 5 (V7). Unscheduled safety visits and early-discontinuation visits are performed as needed.
Endpoints: The primary endpoint is the albuminuria regression rate at 180 days, defined as a reduction in UACR KDIGO albuminuria category (A3 to A2 or A1, or A2 to A1) together with a >=30% reduction in UACR from baseline. Secondary endpoints include the change in UACR, the rate of regression to normoalbuminuria, the proportions achieving >=30/40/50% UACR reduction, KDIGO GFR-Albuminuria category improvement, the change in UACR 30 days after discontinuation, the change in eGFR slope, and the change in blood pressure. Safety endpoints include adverse events, serious adverse events, and adverse events of special interest (notably serum potassium changes and hyperkalemia). Exploratory endpoints also included.
142 studies on the registry are indexed under Albuminuria; 24 are open to participants now.
This study's planned enrollment of 148 is above the median of 69 across 115 interventional studies indexed under Albuminuria.
Browse Albuminuria studies →First Affiliated Hospital of Zhejiang University is the lead sponsor of 263 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
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.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Finerenone film-coated tablets, orally once daily, on top of standard background therapy. Starting dose determined by screening eGFR: 10 mg if 30 \<= eGFR \< 60 mL/min/1.73 m\^2, or 20 mg if eGFR \>= 60 mL/min/1.73 m\^2. Dose up-titrated to 20 mg, maintained, interrupted, or down-titrated to 10 mg based on serum potassium and eGFR. Treatment duration 180 days.
Drug: Finerenone (BAY 94-8862)
Matching placebo tablets identical in appearance to finerenone, orally once daily, on top of standard background therapy, following the same dosing and titration schedule. Treatment duration 180 days.
Drug: Placebo
Oral finerenone 10 mg or 20 mg once daily, with dose titration by serum potassium and eGFR, for 180 days.
Matching placebo tablets, identical in appearance to finerenone, orally once daily, following the same dosing and titration schedule, for 180 days.
Albuminuria regression rate
Proportion of participants achieving albuminuria regression, defined as a reduction in UACR KDIGO albuminuria category (A3 to A2 or A1, or A2 to A1) together with a \>=30% reduction in UACR from baseline.
Time frame: 180 days
Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio
Urinary albumin-to-creatinine ratio will be measured in mg/g. Percent change from baseline will be calculated as: (Day 180 UACR - baseline UACR) / baseline UACR × 100%.
Time frame: Baseline and 180 days
Percentage of Participants With Normoalbuminuria
Normoalbuminuria is defined as urinary albumin-to-creatinine ratio less than 30 mg/g at Day 180.
Time frame: 180 days
Percentage of Participants by UACR Reduction Response Category at Day 180
Percent reduction in urinary albumin-to-creatinine ratio (UACR) from baseline to Day 180 will be calculated for each participant. Participants will be classified into one of four mutually exclusive UACR reduction response categories: no more than 30% reduction, more than 30% to no more than 40% reduction, more than 40% to no more than 50% reduction, and more than 50% reduction. Participants with no reduction or an increase in UACR will be included in the no more than 30% reduction category. The outcome will be reported as the percentage of participants in each response category.
Time frame: Baseline to Day 180
Percentage of Participants With Improvement in Kidney Disease: Improving Global Outcomes Albuminuria Category at Day 180
Improvement in albuminuria category is defined as a change from A3 to A2 or A1, or from A2 to A1, according to Kidney Disease: Improving Global Outcomes urinary albumin-to-creatinine ratio categories.
Time frame: Baseline to Day 180
Change From Day 180 to Day 210 in Urinary Albumin-to-Creatinine Ratio
Change in urinary albumin-to-creatinine ratio from Day 180 to Day 210 will be assessed in mg/g, corresponding to the 30-day off-treatment follow-up period.
Time frame: Day 180 to Day 210
Estimated Glomerular Filtration Rate Slope Through Day 180
Estimated glomerular filtration rate will be calculated using the CKD-EPI equation. The eGFR slope through Day 180 will be estimated from serial eGFR measurements and reported in mL/min/1.73 m2 per year.
Time frame: Baseline through Day 180
Change From Baseline in Systolic Blood Pressure at Day 180
Change in systolic blood pressure from baseline to Day 180 will be assessed in mmHg.
Time frame: Baseline to Day 180
Change From Baseline in Diastolic Blood Pressure at Day 180
Change in diastolic blood pressure from baseline to Day 180 will be assessed in mmHg.
Time frame: Baseline to Day 180
Percentage of Participants With Adverse Events
The outcome will be reported as the percentage of participants experiencing at least one adverse event from first dose through the end of the 30-day off-treatment follow-up period.
Time frame: From first dose through Day 210
Percentage of Participants With Serious Adverse Events
The outcome will be reported as the percentage of participants experiencing at least one serious adverse event from first dose through the end of the 30-day off-treatment follow-up period.
Time frame: From first dose through Day 210
Adverse events of special interest (AESI)
Including change in serum potassium and incidence of hyperkalemia, incidence of eGFR decline \>30% at Day 30, reversibility of eGFR after discontinuation, acute kidney injury, urogenital infection, severe hypoglycemia, symptomatic hypotension, and ketoacidosis
Time frame: Up to 210 days
Change in Composite MRI-PDFF-derived Peri-organ Visceral Fat Fraction
Abdominal magnetic resonance imaging proton density fat fraction will be used to quantify visceral fat fraction (%) in prespecified perirenal, peripancreatic, and perihepatic regions of interest. A composite peri-organ visceral fat fraction will be calculated for each participant as the arithmetic mean of the region-specific MRI-PDFF values from the perirenal, peripancreatic, and perihepatic regions. The outcome will be reported as the percentage-point change in the composite peri-organ visceral fat fraction from baseline to Day 180.
Time frame: Baseline and 180 days
Change in Urine Metabolomic Composite Score
Urine metabolomic features will be measured using a prespecified metabolomics platform. Normalized metabolite feature intensities will be standardized, and a urine metabolomic composite score will be calculated according to the statistical analysis plan. The outcome will be reported as change in composite score from baseline to Day 180.
Time frame: Baseline to Day 180
Plan to share: No — Individual participant data will not be shared publicly.
Start is estimated for Jul 2026; primary completion for Oct 2027, 15 months later.
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Studies of the drug tested here: Finerenone
First Affiliated Hospital of Zhejiang University →