Personalizing kidney treatment: can biomarkers predict who benefits from finerenone?
NCT ID NCT07717697
First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time
Summary
This study follows 425 adults with type 2 diabetes and chronic kidney disease who are taking finerenone, a standard medication. Researchers collect blood and urine samples over four months to look for biomarkers that predict whether the drug helps reduce kidney damage. The goal is to build a model that helps doctors tailor finerenone therapy to each patient.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- finerenone
- What this could lead to
- If successful, this could help doctors predict which patients with diabetic kidney disease will benefit most from finerenone, enabling more personalized treatment.
- What could go wrong
- This is an observational study, not a controlled trial, so it cannot prove cause and effect. The 4-month follow-up is short, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 425 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jul 2026
An estimate. Start dates often move.
- Expected to finish
-
Jan 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diabetic kidney disease are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cost-Effectiveness and implementation of integrated Diabetes-Oral health care in oman: a health belief Model-Based intervention to enhance clinical, behavioral, and exploratory oral microbiome in health system outcomes in type 2 diabetes
- Can a damaged kidney change how a drug works?
- Can ultrasound spot early joint wear in diabetic nerve damage?
- Can a 15-Day wearable sensor keep blood sugar on target?
- Nanoparticle cleaning may calm pain after failed root canals in diabetic patients
- Can a Patient's own kidney cells slow kidney disease?