RecruitingPhase 4NCT07239570

A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease

A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease: A Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study


Sponsor

Peter Rossing

Enrollment

125 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Over 800 million people worldwide suffer from chronic kidney disease (CKD), which is associated with a high individual disease burden for those affected, multiple secondary diseases, frequent doctor contacts, and hospitalizations, but also outstanding costs for the health system and the solidarity community. Appropriate interventions are essential to prevent the development and progression of CKD. In the past decade, great progress has been made in the search for drugs that can slow the progression of CKD. Sodium-glucose co-transporter 2 inhibitors, the non-steroidal mineralocorticoid receptor antagonist, finerenone, and the glucagon-like peptide-1 receptor agonist, semaglutide, have demonstrated albuminuria-lowering effects and kidney protection in people with CKD. Although these new pharmacological approaches show great promise, it is unclear how to optimally sequence and combine these therapies. In addition, the therapies are often not implemented due to treatment inertia and fear of adverse effects. This study aims to address this knowledge gap by utilizing a biomarker-guided treatment approach to reduce the decline in kidney function. The aim of the CKD-bioMatch study is to evaluate the efficacy of a biomarker-targeted treatment approach versus standard of care in people with CKD and albuminuria. We hypothesize that a biomarker-targeted treatment approach is superior to standard of care at reducing estimated glomerular filtration rate (eGFR) decline in people with CKD.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a biomarker-guided approach to treat chronic kidney disease (CKD). By measuring specific proteins in urine, researchers aim to match patients to one of three drugs — a SGLT2 inhibitor, a GLP-1 receptor agonist, or a mineralocorticoid receptor antagonist — to see which combination most effectively slows kidney disease progression. **You may be eligible if...** - You are 18 to 75 years old - You have significant protein in your urine (a marker of kidney damage) on two consecutive tests - You are on the maximum tolerated dose of a blood pressure medication that protects the kidneys (ACE inhibitor or ARB) for at least 4 weeks - You can communicate with study staff and sign informed consent **You may NOT be eligible if...** - Your kidney function is severely reduced (eGFR below 25) - You are already taking two or more of the study drugs - You have a history of pancreatitis - You have a very low BMI (under 18.5) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDapagliflozin

Dapagliflozin 10 mg daily.

DRUGSemaglutide

Semaglutide injection once weekly. Will be titrated every 4 weeks to the highest tolerable dose according to standard guidelines, aiming at 1 mg once weekly.

DRUGFinerenone

Finerenone 10-20 mg daily.


Locations(4)

Steno Diabetes Center Copenhagen

Herlev, Denmark

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Hospital Clinico de Valencia

Valencia, Spain

Lund University

Malmö, Sweden

View Full Details on ClinicalTrials.gov

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NCT07239570


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