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AlbuminuriaPhase 4NCT07667517

Finerenone for Regression of Albuminuria in Type 2 Diabetes With Chronic Kidney Disease

A Phase 4 study testing Finerenone (BAY 94-8862) in people with Albuminuria and Type 2 Diabetes Mellitus (T2DM), run by First Affiliated Hospital of Zhejiang University at 13 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Finerenone (BAY 94-8862)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
148 participants
Where
13 sitesChina
Study dates
1 Jul 2026to 31 Dec 2027
Phase
Phase 4
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

  • 1. Age >= 18 years at the time of signing informed consent, male or female.
  • 2. Type 2 diabetes mellitus.
  • 3. Chronic kidney disease meeting BOTH of the following: eGFR (CKD-EPI) >= 30 mL/min/1.73 m^2, and UACR 30-2000 mg/g (mean of 3 measurements).
  • 4. Serum potassium <= 5.0 mmol/L.
  • 5. On a maximum tolerated dose of an ACE inhibitor or ARB for at least 90 days.
  • 6. Treatment with an SGLT-2 inhibitor, GLP-1 receptor agonist, or other agents affecting UACR is permitted, but the type and dose must be stable for at least 30 days before screening.

Who cannot join

  • 1. Type 1 diabetes, other specific types of diabetes, or gestational diabetes.
  • 2. HbA1c >= 8.0%.
  • 3. On renal replacement therapy.
  • 4. Acute kidney injury within 180 days before the screening visit.
  • 5. Hepatic impairment (Child-Pugh class C).
  • 6. Blood pressure > 160/100 mmHg, or systolic blood pressure < 90 mmHg, at the screening visit.
Show all 22Show fewer
  • 7. Bilateral renal artery stenosis.
  • 8. Known hypersensitivity to the study drug (active substance or excipients).
  • 9. Treatment with finerenone within 60 days before screening.
  • 10. Stroke, transient ischemic attack, acute coronary syndrome (myocardial infarction, CABG, PCI), or hospitalization for worsening heart failure within 90 days before the screening visit.
  • 11. NYHA class II-IV heart failure.
  • 12. Addison's disease.
  • 13. Gastrointestinal surgery that may affect drug absorption.
  • 14. Any other history, condition, therapy, or uncontrolled concomitant disease that makes the participant unsuitable for the study or unlikely to complete it (e.g., active malignancy or other disease with life expectancy < 12 months).
  • 15. Treatment with a strong CYP3A4 inhibitor (e.g., itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin, nefazodone), a strong CYP3A4 inducer (e.g., carbamazepine, phenytoin, phenobarbital, St. John's wort), or a moderate CYP3A4 inducer (e.g., efavirenz) that cannot be discontinued for at least 7 days before randomization.
  • 16. Treatment with another mineralocorticoid receptor antagonist (e.g., spironolactone, eplerenone, esaxerenone) or a potassium-sparing diuretic (e.g., amiloride, triamterene) that cannot be discontinued for at least 60 days before the screening visit.
  • 17. Biopsy-confirmed non-diabetic kidney disease (e.g., IgA nephropathy).
  • 18. Immunosuppressive therapy, or glucocorticoid use by any route other than topical or inhaled, within the past 180 days.
  • 19. Participation in another interventional clinical study or use of any investigational product within 90 days before randomization.
  • 20. History of alcohol or drug abuse.
  • 21. Women of childbearing potential who are pregnant, breastfeeding, intend to become pregnant, or are not using adequate contraception during the study.
  • 22. Any other condition deemed by the investigator to make the participant unsuitable for the study.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yuejun Liu contact

+8613472844268

yuejunliu7@126.com

13 sites in 1 country

China13 sites

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Zhihong Wang, +8613883021919

  • Sanshui Hospital, Zhujiang Hospital, Southern Medical University

    Foshan, Guangdong

    Zhen Zhang, +8615913162742

  • Fujian Provincial Hospital

    Fuzhou, Fujian

    Junping Wen, +8613559925729

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong

    Junyu Xue, +8618613166333

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Peng Yu, 18818211531, ypbaggio@163.com

  • Nantong First People's Hospital

    Nantong, Jiangsu

    Xueqin Wang, +8613813609566

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang

    Li Li, +8613757426626

  • Shanghai Municipal Hospital of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality

    Feng Tao, +8613818808324

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality

    Yuejuan Liu, +8613472844268

  • The First People's Hospital of Suqian

    Suqian, Jiangsu

    Hong Zhu, +8618012186759

  • Suzhou Science and Technology City Hospital

    Suzhou, Jiangsu

    Zhimin Ma, +8617715187073

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Hong Zhu, +8613758712421

  • Xi'an Daxing Hospital

    Xi'an, Shaanxi

    Ying Xing, +8613991955717

Other trials in China

About this study

Official title: Efficacy and Safety of Finerenone for the Early Regression of Albuminuria in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

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.

Read the detailed description

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.

Being tested
Finerenone (BAY 94-8862), Placebo
Keywords
Finerenone, Nonsteroidal mineralocorticoid receptor antagonist, Urine albumin-to-creatinine ratio, KDIGO, Albuminuria regression
Medical subject headings
Albuminuria, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Finerenone (BAY 94-8862)Drug

    Oral finerenone 10 mg or 20 mg once daily, with dose titration by serum potassium and eGFR, for 180 days.

  • PlaceboDrug

    Matching placebo tablets, identical in appearance to finerenone, orally once daily, following the same dosing and titration schedule, for 180 days.

Study groups in NCT07667517
Study groupRoleWhat they receive
FinerenoneExperimentalFinerenone 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.
Receives: Drug: Finerenone (BAY 94-8862)
PlaceboPlacebo comparatorMatching 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 180 days

Secondary outcomes (8)

  1. 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%.

    Measured: Baseline and 180 days

  2. Percentage of Participants With Normoalbuminuria

    Normoalbuminuria is defined as urinary albumin-to-creatinine ratio less than 30 mg/g at Day 180.

    Measured: 180 days

  3. 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.

    Measured: Baseline to Day 180

  4. 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.

    Measured: Baseline to Day 180

  5. 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.

    Measured: Day 180 to Day 210

  6. 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.

    Measured: Baseline through Day 180

  7. 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.

    Measured: Baseline to Day 180

  8. 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.

    Measured: Baseline to Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07667517
Sponsor's protocol ID
[2026C]IIT No.001
Status last verified
Jun 2026
First submitted
14 Jun 2026
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared publicly.

Publications

  • Heerspink HJ, Gao P, de Zeeuw D, Clase C, Dagenais GR, Sleight P, Lonn E, Teo KT, Yusuf S, Mann JF. The effect of ramipril and telmisartan on serum potassium and its association with cardiovascular and renal events: results from the ONTARGET trial. Eur J Prev Cardiol. 2014 Mar;21(3):299-309. doi: 10.1177/2047487313510678. Epub 2013 Nov 4.

    PubMed 24191305

  • Coresh J, Grams ME, Chen TK. Using GFR, Albuminuria, and Their Changes in Clinical Trials and Clinical Care. Am J Kidney Dis. 2021 Sep;78(3):333-334. doi: 10.1053/j.ajkd.2021.04.003. Epub 2021 May 28. No abstract available.

    PubMed 34059333

  • Inker LA, Heerspink HJL, Tighiouart H, Chaudhari J, Miao S, Diva U, Mercer A, Appel GB, Donadio JV, Floege J, Li PKT, Maes BD, Locatelli F, Praga M, Schena FP, Levey AS, Greene T. Association of Treatment Effects on Early Change in Urine Protein and Treatment Effects on GFR Slope in IgA Nephropathy: An Individual Participant Meta-analysis. Am J Kidney Dis. 2021 Sep;78(3):340-349.e1. doi: 10.1053/j.ajkd.2021.03.007. Epub 2021 Mar 26.

    PubMed 33775708

  • Lambers Heerspink HJ, Gansevoort RT. Albuminuria Is an Appropriate Therapeutic Target in Patients with CKD: The Pro View. Clin J Am Soc Nephrol. 2015 Jun 5;10(6):1079-88. doi: 10.2215/CJN.11511114. Epub 2015 Apr 17.

    PubMed 25887073

  • Levey AS, Gansevoort RT, Coresh J, Inker LA, Heerspink HL, Grams ME, Greene T, Tighiouart H, Matsushita K, Ballew SH, Sang Y, Vonesh E, Ying J, Manley T, de Zeeuw D, Eckardt KU, Levin A, Perkovic V, Zhang L, Willis K. Change in Albuminuria and GFR as End Points for Clinical Trials in Early Stages of CKD: A Scientific Workshop Sponsored by the National Kidney Foundation in Collaboration With the US Food and Drug Administration and European Medicines Agency. Am J Kidney Dis. 2020 Jan;75(1):84-104. doi: 10.1053/j.ajkd.2019.06.009. Epub 2019 Aug 28.

    PubMed 31473020

  • Heerspink HJL, Greene T, Tighiouart H, Gansevoort RT, Coresh J, Simon AL, Chan TM, Hou FF, Lewis JB, Locatelli F, Praga M, Schena FP, Levey AS, Inker LA; Chronic Kidney Disease Epidemiology Collaboration. Change in albuminuria as a surrogate endpoint for progression of kidney disease: a meta-analysis of treatment effects in randomised clinical trials. Lancet Diabetes Endocrinol. 2019 Feb;7(2):128-139. doi: 10.1016/S2213-8587(18)30314-0. Epub 2019 Jan 8.

    PubMed 30635226

  • Fox CS, Matsushita K, Woodward M, Bilo HJ, Chalmers J, Heerspink HJ, Lee BJ, Perkins RM, Rossing P, Sairenchi T, Tonelli M, Vassalotti JA, Yamagishi K, Coresh J, de Jong PE, Wen CP, Nelson RG; Chronic Kidney Disease Prognosis Consortium. Associations of kidney disease measures with mortality and end-stage renal disease in individuals with and without diabetes: a meta-analysis. Lancet. 2012 Nov 10;380(9854):1662-73. doi: 10.1016/S0140-6736(12)61350-6. Epub 2012 Sep 24.

    PubMed 23013602

  • Marup FH, Thomsen MB, Birn H. Additive effects of dapagliflozin and finerenone on albuminuria in non-diabetic CKD: an open-label randomized clinical trial. Clin Kidney J. 2023 Sep 26;17(1):sfad249. doi: 10.1093/ckj/sfad249. eCollection 2024 Jan.

    PubMed 38186886

  • Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Brinker M, Edfors R, Li N, Scheerer MF, Scott C, Nangaku M; CONFIDENCE Investigators. Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes. N Engl J Med. 2025 Aug 7;393(6):533-543. doi: 10.1056/NEJMoa2410659. Epub 2025 Jun 5.

    PubMed 40470996

  • Agarwal R, Tu W, Farjat AE, Farag YMK, Toto R, Kaul S, Lawatscheck R, Rohwedder K, Ruilope LM, Rossing P, Pitt B, Filippatos G, Anker SD, Bakris GL; FIDELIO-DKD and FIGARO-DKD Investigators. Impact of Finerenone-Induced Albuminuria Reduction on Chronic Kidney Disease Outcomes in Type 2 Diabetes : A Mediation Analysis. Ann Intern Med. 2023 Dec;176(12):1606-1616. doi: 10.7326/M23-1023. Epub 2023 Dec 5.

    PubMed 38048573

  • Agarwal R, Filippatos G, Pitt B, Anker SD, Rossing P, Joseph A, Kolkhof P, Nowack C, Gebel M, Ruilope LM, Bakris GL; FIDELIO-DKD and FIGARO-DKD investigators. Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis. Eur Heart J. 2022 Feb 10;43(6):474-484. doi: 10.1093/eurheartj/ehab777.

    PubMed 35023547

  • Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris GL, Rossing P, Joseph A, Kolkhof P, Nowack C, Schloemer P, Ruilope LM; FIGARO-DKD Investigators. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021 Dec 9;385(24):2252-2263. doi: 10.1056/NEJMoa2110956. Epub 2021 Aug 28.

    PubMed 34449181

  • Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.

    PubMed 33264825

  • 中华医学会糖尿病学分会, 国家基层公共卫生服务项目基础糖尿病防治管理办公室. 国家基层糖 尿病肾脏病防治技术指南 (2023). 中华内科杂志, 2023, 62(12): 1394-1405

  • American Diabetes Association Professional Practice Committee. 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S179-S218. doi: 10.2337/dc24-S010.

    PubMed 38078592

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Finerenone (BAY 94-8862) in people with Albuminuria and Type 2 Diabetes Mellitus (T2DM), run by First Affiliated Hospital of Zhejiang University at 13 sites in China.

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 22 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 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. 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. Some participants in this study may receive a placebo. 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?

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 Yuejun Liu (+8613472844268, yuejunliu7@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Albuminuria regression rate (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07667517, which also lists 18 linked publications.

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 25 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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