Type 2 Diabetes MellitusNCT07717697
Finerenone for the Treatment of Type 2 Diabetes-Related Kidney Disease: Efficacy Observation and Related Factor Analysis
An observational study of Type 2 Diabetes Mellitus and Diabetic Kidney Disease, run by First Affiliated Hospital of Chongqing Medical University.
Trial summary
This is a single-center prospective observational clinical study conducted at the First Affiliated Hospital of Chongqing Medical University. A total of 425 patients aged 18-75 years with type 2 diabetes mellitus-related chronic kidney disease will be enrolled from February 2026 to January 2029. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetic Kidney Disease
- What is being tested?
- Finerenone
- Type of treatment
- Pill or oral medicine
- How many people
- 425 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to 30 Jan 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective observational cohort study enrolling patients with type 2 diabetes mellitus (T2DM) complicated with chronic kidney disease (CKD) receiving finerenone therapy. Subjects will be recruited from the Chongqing Diabetes Registry (CDR), endocrine outpatient and inpatient departments of the First Affiliated Hospital of Chongqing Medical University, with a recruitment window from February 2026 to January 2029. A total of 425 eligible participants are planned to be enrolled. A target sample size of 425 participants is determined using the R pmsampsize package for predictive model development. Key input parameters: C-statistic of 0.80, 10 candidate predictive variables, expected finerenone responder proportion of 53.2% derived from FIDELIO-DKD and FIGARO-DKD trials. The minimum required sample size to satisfy model stability and calibration criteria is 383 participants. A 10% attrition rate is accounted for, leading to the final enrolment target of 425 patients.
Who may be able to join
- Aged 18-75 years, male or female, with full capacity for independent conduct.
- Confirmed type 2 diabetes-associated chronic kidney disease (CKD): Random urine albumin-to-creatinine ratio (UACR) of 100-5000 ug/mg Cr on two non-consecutive days; estimated glomerular filtration rate (eGFR) calculated by the CKD-EPI formula >25 mL/min/1.73m²; Finerenone treatment is indicated per clinical guidelines.
- All concomitant medications have remained stable for 3 months prior to screening, with no planned treatment adjustments throughout the trial. Stable medication is defined as dose adjustments not exceeding ±25% of the screening baseline dose.
- If the glycemic regimen includes sodium-glucose cotransporter 2 inhibitors (SGLT-2i): The daily SGLT-2i dose remains constant for 3 months before screening, and no daily dose changes are planned during the entire trial. If the glycemic regimen excludes SGLT-2i: No SGLT-2i exposure within 4 weeks prior to screening, and no SGLT-2i initiation is planned throughout the trial.
- If the glycemic regimen includes glucagon-like peptide-1 receptor agonists (GLP-1RA): The daily GLP-1RA dose remains constant for 3 months before screening, and no daily dose changes are planned during the entire trial. If the glycemic regimen excludes GLP-1RA: No GLP-1RA exposure within 4 weeks prior to screening, and no GLP-1RA initiation is planned throughout the trial.
- Fully understands the entire trial procedure, voluntarily participates in the study and signs the informed consent form.
Who cannot join
- Diagnosed or suspected type 1 diabetes, special type diabetes or secondary diabetes.
- Poor glycemic control with glycated hemoglobin (HbA1c) >9.0%.
- Average seated office blood pressure measured over 3 visits with systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg.
- Serum potassium >5.0 mmol/L without potassium supplementation.
- Diagnosed or suspected chronic kidney disease unrelated to diabetic nephropathy.
- Complicated with liver cirrhosis or moderate-to-severe liver impairment.
Show all 15Show fewer
- Patients with secondary aldosteronism and primary aldosteronism who have surgery plans within six months.
- Confirmed Addison's disease.
- Complicated with uncontrolled autoimmune diseases.
- Complicated with active malignant tumors.
- Presence or suspicion of depression, bipolar disorder, suicidal tendency, schizophrenia or other severe mental illnesses; or lack of mental capacity or language barrier, unable to fully understand the trial protocol or unwilling to cooperate with study site staff.
- Complicated with other uncontrolled chronic diseases.
- Use of serum potassium-elevating agents (e.g., amiloride, triamterene) or other mineralocorticoid receptor antagonists (MRAs, e.g., spironolactone, eplerenone) within 4 weeks prior to screening.
- Use of strong CYP3A4 inhibitors (itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone) or CYP3A4 inducers (carbamazepine, phenytoin, erythromycin, fluvoxamine) within 2 weeks prior to screening.
- Pregnant or breastfeeding women.
About this study
This is a single-center prospective observational clinical study conducted at the First Affiliated Hospital of Chongqing Medical University. A total of 425 patients aged 18-75 years with type 2 diabetes mellitus-related chronic kidney disease will be enrolled from February 2026 to January 2029. All participants will receive standard finerenone treatment in accordance with clinical guidelines with a 4-month follow-up period. Blood and urine samples will be collected at screening, baseline, 1 month, 2 months and 4 months after treatment initiation for routine biochemistry, aldosterone/renin testing, captopril suppression test and multi-omics analysis.
Participants will be categorized into benefit group, partial benefit group and non-benefit group based on the reduction rate of urine albumin-to-creatinine ratio (UACR) at Month 4. We will combine demographic data, laboratory indicators and multi-omics profiles to identify key biomarkers predicting finerenone response, and construct a predictive model to realize precise individualized therapy for diabetic kidney disease.
All study-related laboratory tests are free of charge for subjects. A priority consultation channel is available during follow-up, and free professional consultation on diabetic nephropathy will be provided. Serum potassium and renal function will be closely monitored to manage safety risks such as hyperkalemia. All personal data and biological samples are anonymized and stored in encrypted systems with strict confidentiality protection. Subjects may withdraw from the study voluntarily at any time without interference to their routine clinical care.
Read the detailed description
This single-center prospective observational cohort study will recruit 425 eligible adult patients aged 18-75 years diagnosed with type 2 diabetes mellitus associated chronic kidney disease (T2DM-CKD) from the Chongqing Diabetes Registry, endocrine wards and outpatient clinics of the First Affiliated Hospital of Chongqing Medical University between February 2026 and January 2029. All enrolled subjects will receive guideline-directed finerenone oral therapy for a 4-month observation period, with dose adjusted based on baseline eGFR and serum potassium levels per drug instructions.
Serial blood and urine biospecimens will be collected at screening, baseline, month 1, month 2 and month 4 visits. Collected samples will be tested for routine biochemistry, electrolytes, renal function, HbA1c, plasma renin and aldosterone; captopril suppression test and multi-omics profiling will also be performed at designated time points.
According to the percentage reduction of urine albumin-to-creatinine ratio (UACR) at month 4, participants will be stratified into three subgroups: benefit group (UACR reduction ≥30%), partial benefit group (10% ≤ UACR reduction <30%), and non-benefit group (UACR reduction <10% or elevated UACR). Primary objective is to identify core biomarkers associated with finerenone therapeutic response. Secondary outcomes include serial changes in eGFR, UACR, serum potassium, aldosterone and renin across all follow-up time points.
Sample size calculation was performed using R pmsampsize package, accounting for a 10% anticipated loss to follow-up to reach the target sample of 425 subjects. All statistical analyses will be conducted via R and Python with machine learning algorithms to develop and validate a predictive model for finerenone efficacy.
Safety monitoring including serum potassium and renal function assessment will be conducted at every visit. Subjects with hyperkalemia or progressive renal impairment will suspend finerenone per predefined criteria. All study-related laboratory examinations are provided free of charge to participants, with priority medical consultation service available throughout follow-up. All personal clinical data and biological samples are anonymized and stored under encrypted management to protect participant privacy. Subjects may withdraw consent at any time without impact on routine clinical treatment. Study findings will be summarized and published in peer-reviewed journals after data collection is fully completed.
- Conditions
- Type 2 Diabetes Mellitus, Diabetic Kidney Disease
- Being tested
- Finerenone
- Keywords
- Finerenone, Type 2 diabetes mellitus, Diabetic kidney disease, Predictive model, Prospective observational study
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
Oral finerenone administered once daily for 4 months. Dosage is individualized based on baseline estimated glomerular filtration rate (eGFR) and serum potassium per drug labeling. Subjects maintain stable background hypoglycemic, antihypertensive and lipid-lowering therapies throughout the observational period. No additional study-specific drugs or experimental procedures are applied; only routine clinical finerenone treatment is observed with serial blood and urine sample collection for multi-omics and biomarker analysis.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone Treatment Cohort | All enrolled participants with type 2 diabetes mellitus-related chronic kidney disease receive guideline-standard oral finerenone therapy for a 4-month observation period. The finerenone dose is adjusted according to each subject's baseline eGFR and serum potassium level following the official drug instructions. Concomitant hypoglycemic, antihypertensive and lipid-lowering medications remain stable during the whole study period as required by inclusion criteria. Serial blood and urine biospecimens are collected at multiple follow-up time points for routine biochemical tests, captopril suppression test and multi-omics detection. After 4 months of treatment, subjects will be divided into three analytic subgroups based on UACR reduction rate to explore predictive biomarkers of finerenone efficacy. Receives: Drug: Finerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Key biomarkers associated with therapeutic response to finerenone
Identify core multi-omics, biochemical and clinical biomarkers that predict whether patients with type 2 diabetes-related chronic kidney disease can achieve renal benefit from finerenone treatment.
Measured: 4 months after finerenone initiation
Secondary outcomes (4)
Percentage change in urine albumin-to-creatinine ratio (UACR) from baseline to Month 4
Stratify participants into benefit (UACR reduction ≥30%), partial benefit (10% ≤ UACR reduction <30%), non-benefit (reduction <10% or increased UACR) based on UACR decline at Month 4.
Measured: Baseline, Month 4
Serial change in estimated glomerular filtration rate (eGFR)
Dynamic variation of eGFR at each follow-up visit compared with baseline.
Measured: Baseline, Month 1, Month 2, Month 4
Serial change in serum potassium
Continuous monitoring of serum potassium to assess the risk of hyperkalemia during finerenone treatment.
Measured: Baseline, Month 1, Month 2, Month 4
Changes in plasma aldosterone and renin at Month 4
Difference of plasma aldosterone and renin levels between baseline and Month 4 after finerenone intervention.
Measured: Baseline, Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Jan 2029 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe 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
- Prospective
- Enrolment
- 425 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong Wang, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717697
- Sponsor's protocol ID
- 2026-0256-01
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finerenone for the Treatment of Type 2 Diabetes-Related Kidney Disease: Efficacy Observation and Related Factor Analysis
- ClinicalTrials.gov ID
- NCT07717697
- Acronym / sponsor ID
- 2026-0256-01
- Conditions
- Type 2 Diabetes Mellitus, Diabetic Kidney Disease
- Keywords
- Finerenone, Type 2 diabetes mellitus, Diabetic kidney disease, Predictive model, Prospective observational study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 21 Jul 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.
This is a single-center prospective observational clinical study conducted at the First Affiliated Hospital of Chongqing Medical University. A total of 425 patients aged 18-75 years with type 2 diabetes mellitus-related chronic kidney disease will be enrolled from February 2026 to January 2029. All participants will receive standard finerenone treatment in accordance with clinical guidelines with a 4-month follow-up period. Blood and urine samples will be collected at screening, baseline, 1 month, 2 months and 4 months after treatment initiation for routine biochemistry, aldosterone/renin testing, captopril suppression test and multi-omics analysis.
Participants will be categorized into benefit group, partial benefit group and non-benefit group based on the reduction rate of urine albumin-to-creatinine ratio (UACR) at Month 4. We will combine demographic data, laboratory indicators and multi-omics profiles to identify key biomarkers predicting finerenone response, and construct a predictive model to realize precise individualized therapy for diabetic kidney disease.
All study-related laboratory tests are free of charge for subjects. A priority consultation channel is available during follow-up, and free professional consultation on diabetic nephropathy will be provided. Serum potassium and renal function will be closely monitored to manage safety risks such as hyperkalemia. All personal data and biological samples are anonymized and stored in encrypted systems with strict confidentiality protection. Subjects may withdraw from the study voluntarily at any time without interference to their routine clinical care.
Detailed description
This single-center prospective observational cohort study will recruit 425 eligible adult patients aged 18-75 years diagnosed with type 2 diabetes mellitus associated chronic kidney disease (T2DM-CKD) from the Chongqing Diabetes Registry, endocrine wards and outpatient clinics of the First Affiliated Hospital of Chongqing Medical University between February 2026 and January 2029. All enrolled subjects will receive guideline-directed finerenone oral therapy for a 4-month observation period, with dose adjusted based on baseline eGFR and serum potassium levels per drug instructions.
Serial blood and urine biospecimens will be collected at screening, baseline, month 1, month 2 and month 4 visits. Collected samples will be tested for routine biochemistry, electrolytes, renal function, HbA1c, plasma renin and aldosterone; captopril suppression test and multi-omics profiling will also be performed at designated time points.
According to the percentage reduction of urine albumin-to-creatinine ratio (UACR) at month 4, participants will be stratified into three subgroups: benefit group (UACR reduction ≥30%), partial benefit group (10% ≤ UACR reduction <30%), and non-benefit group (UACR reduction <10% or elevated UACR). Primary objective is to identify core biomarkers associated with finerenone therapeutic response. Secondary outcomes include serial changes in eGFR, UACR, serum potassium, aldosterone and renin across all follow-up time points.
Sample size calculation was performed using R pmsampsize package, accounting for a 10% anticipated loss to follow-up to reach the target sample of 425 subjects. All statistical analyses will be conducted via R and Python with machine learning algorithms to develop and validate a predictive model for finerenone efficacy.
Safety monitoring including serum potassium and renal function assessment will be conducted at every visit. Subjects with hyperkalemia or progressive renal impairment will suspend finerenone per predefined criteria. All study-related laboratory examinations are provided free of charge to participants, with priority medical consultation service available throughout follow-up. All personal clinical data and biological samples are anonymized and stored under encrypted management to protect participant privacy. Subjects may withdraw consent at any time without impact on routine clinical treatment. Study findings will be summarized and published in peer-reviewed journals after data collection is fully completed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Finerenone Treatment Cohort | – | Drug: FinerenoneAll enrolled participants with type 2 diabetes mellitus-related chronic kidney disease receive guideline-standard oral finerenone therapy for a 4-month observation period. The finerenone dose is adjusted according to each subject's baseline eGFR and serum potassium level following the official drug instructions. Concomitant hypoglycemic, antihypertensive and lipid-lowering medications remain stable during the whole study period as required by inclusion criteria. Serial blood and urine biospecimens are collected at multiple follow-up time points for routine biochemical tests, captopril suppression test and multi-omics detection. After 4 months of treatment, subjects will be divided into three analytic subgroups based on UACR reduction rate to explore predictive biomarkers of finerenone efficacy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective observational cohort study enrolling patients with type 2 diabetes mellitus (T2DM) complicated with chronic kidney disease (CKD) receiving finerenone therapy. Subjects will be recruited from the Chongqing Diabetes Registry (CDR), endocrine outpatient and inpatient departments of the First Affiliated Hospital of Chongqing Medical University, with a recruitment window from February 2026 to January 2029. A total of 425 eligible participants are planned to be enrolled. A target sample size of 425 participants is determined using the R pmsampsize package for predictive model development. Key input parameters: C-statistic of 0.80, 10 candidate predictive variables, expected finerenone responder proportion of 53.2% derived from FIDELIO-DKD and FIGARO-DKD trials. The minimum required sample size to satisfy model stability and calibration criteria is 383 participants. A 10% attrition rate is accounted for, leading to the final enrolment target of 425 patients.
Key inclusion criteria (6 listed)
- Aged 18-75 years, male or female, with full capacity for independent conduct.
- Confirmed type 2 diabetes-associated chronic kidney disease (CKD): Random urine albumin-to-creatinine ratio (UACR) of 100-5000 ug/mg Cr on two non-consecutive days; estimated glomerular filtration rate (eGFR) calculated by the CKD-EPI formula >25 mL/min/1.73m²; Finerenone treatment is indicated per clinical guidelines.
- All concomitant medications have remained stable for 3 months prior to screening, with no planned treatment adjustments throughout the trial. Stable medication is defined as dose adjustments not exceeding ±25% of the screening baseline dose.
- If the glycemic regimen includes sodium-glucose cotransporter 2 inhibitors (SGLT-2i): The daily SGLT-2i dose remains constant for 3 months before screening, and no daily dose changes are planned during the entire trial. If the glycemic regimen excludes SGLT-2i: No SGLT-2i exposure within 4 weeks prior to screening, and no SGLT-2i initiation is planned throughout the trial.
- If the glycemic regimen includes glucagon-like peptide-1 receptor agonists (GLP-1RA): The daily GLP-1RA dose remains constant for 3 months before screening, and no daily dose changes are planned during the entire trial. If the glycemic regimen excludes GLP-1RA: No GLP-1RA exposure within 4 weeks prior to screening, and no GLP-1RA initiation is planned throughout the trial.
Key exclusion criteria (15 listed)
- Diagnosed or suspected type 1 diabetes, special type diabetes or secondary diabetes.
- Poor glycemic control with glycated hemoglobin (HbA1c) >9.0%.
- Average seated office blood pressure measured over 3 visits with systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg.
- Serum potassium >5.0 mmol/L without potassium supplementation.
- Diagnosed or suspected chronic kidney disease unrelated to diabetic nephropathy.
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 |
|---|---|---|
| FinerenoneOral finerenone administered once daily for 4 months. Dosage is individualized based on baseline estimated glomerular filtration rate (eGFR) and serum potassium per drug labeling. Subjects maintain stable background hypoglycemic, antihypertensive and lipid-lowering therapies throughout the observational period. No additional study-specific drugs or experimental procedures are applied; only routine clinical finerenone treatment is observed with serial blood and urine sample collection for multi-omics and biomarker analysis. | Drug | Finerenone Treatment Cohort |
Primary outcome
Key biomarkers associated with therapeutic response to finerenone
Time frame: 4 months after finerenone initiation
Identify core multi-omics, biochemical and clinical biomarkers that predict whether patients with type 2 diabetes-related chronic kidney disease can achieve renal benefit from finerenone treatment.
4 secondary outcomes
Percentage change in urine albumin-to-creatinine ratio (UACR) from baseline to Month 4
Time frame: Baseline, Month 4
Serial change in estimated glomerular filtration rate (eGFR)
Time frame: Baseline, Month 1, Month 2, Month 4
Serial change in serum potassium
Time frame: Baseline, Month 1, Month 2, Month 4
Changes in plasma aldosterone and renin at Month 4
Time frame: Baseline, Month 4
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 21 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Diabetic Kidney Disease, run by First Affiliated Hospital of Chongqing Medical University.
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 15 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 21 Jul 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?
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?
Key biomarkers associated with therapeutic response to finerenone (time frame: 4 months after finerenone initiation). 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 21 Jul 2026.