Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
NCT07239570

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

Led by Peter Rossing · Updated on 2025-11-20

125

Participants Needed

4

Research Sites

153 weeks

Total Duration

On this page

Sponsors

P

Peter Rossing

Lead Sponsor

U

University Medical Center Groningen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Urinary albumin-to-creatinine ratio (UACR) between 100 and 5000 mg/g in two consecutive urine samples at screening (80-100 mg/g accepted if previous measurements were above 100 mg/g without new treatment)
  • Stable treatment with maximum tolerated dose of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for at least four weeks prior to randomization, unless contraindicated or not tolerated
  • Ability to communicate with study staff and understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Estimated glomerular filtration rate (eGFR) less than 25 mL/min/1.73m2 at screening
  • Treatment with two or all three study drugs (dapagliflozin, finerenone, semaglutide)
  • History of pancreatitis
  • Body mass index less than 18.5 kg/m2
  • Type 1 diabetes
  • Heart attack, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrollment
  • New York Heart Association (NYHA) class IV congestive heart failure
  • Blood potassium level greater than 5.0 mmol/L
  • Addison's disease
  • Use of strong CYP3A4 inhibitors
  • Treatment with potassium-sparing diuretics or mineralocorticoid receptor antagonists except finerenone
  • Elevated liver enzymes or severe liver disease
  • Polycystic kidney disease
  • Lupus nephritis, ANCA-associated vasculitis, or other immunosuppressive-requiring kidney diseases within 6 months
  • Kidney transplant or dialysis
  • Known or suspected allergy to study medications
  • History of malignant tumors except certain skin cancers within 5 years
  • Other conditions affecting safety or study compliance
  • Pregnant, breastfeeding, or intending pregnancy without effective contraception
  • Known or suspected narcotics abuse
  • Participation in another intervention study
  • Vulnerable or mentally incapacitated individuals unable to consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Steno Diabetes Center Copenhagen

Herlev, Denmark

Actively Recruiting

2

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Not Yet Recruiting

3

Hospital Clinico de Valencia

Valencia, Spain

Not Yet Recruiting

4

Lund University

Malmö, Sweden

Not Yet Recruiting

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Research Team

P

Peter Rossing

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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