Personalizing kidney treatment: can biomarkers predict who benefits from finerenone?

NCT ID NCT07717697

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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