Actively Recruiting
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
Eligibility Criteria
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
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
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
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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