Biomarker-guided treatment strategy for chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CKD-bioMatch is a prospective, randomized, open-label, parallel-group, multicenter study that will enroll 125 adults with CKD and elevated albuminuria and randomize them 1:1 to biomarker-targeted treatment versus standard of care. In the biomarker arm, participants begin one of three medications (dapagliflozin, finerenone, or semaglutide) and have urinary albumin-to-creatinine ratio (UACR) and urinary epidermal growth factor (UEGF) measured after approximately four weeks on the maximum tolerated dose. Based on the biomarker response, clinicians will decide to continue, switch, or add another study medication and repeat the four-week biomarker evaluation for each change. The comparator arm receives usual guideline-based care, and the study compares biomarker-guided sequencing to standard practice across several European centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years
2. UACR 100-5000 mg/g (11.3-565 mg/mmol) in two consecutive first-morning void urine samples at screening. (UACR 80-100 mg/g is accepted if historical measurements are above 100 mg/g and if it cannot be explained by any new treatment.)
3. Stable treatment with a maximum tolerated dose of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for at least four weeks prior to randomization. (Unless such treatment is contraindicated or not tolerated.)
4. Ability to communicate with the study staff and understand and sign the informed consent.

Exclusion Criteria:

1. eGFR \< 25 mL/min/1.73m2 at screening.
2. Treatment with two or all three of the study drugs
3. History of pancreatitis at screening
4. Body mass index \< 18.5 kg/m2 at screening
5. Type 1 diabetes
6. Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrollment
7. NYHA class IV Congestive Heart Failure at screening
8. Potassium \> 5.0 mmol/L at screening
9. Addison's Disease
10. Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, cobicistat, clarithromycin)
11. Treatment with a potassium-sparing diuretic or a mineralocorticoid receptor antagonist, except for finerenone (e.g., spironolactone, eplerenone, or amiloride)
12. Elevated Alanine Aminotransferase (ALT) \> 3 x upper normal limit at screening, autoimmune hepatitis, and/or severe hepatic impairment (including but not limited to a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt).
13. Autosomal dominant or autosomal recessive polycystic kidney disease
14. Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening
15. Kidney transplant or dialysis
16. Known or suspected hypersensitivity to the study medications or related products
17. Presence or history of malignant neoplasms (except basal cell skin cancer or squamous cell skin cancer) within five years before screening.
18. Any other history, condition, therapy, or uncontrolled intercurrent illness that could, as judged by the investigator, affect participant safety or compliance with study requirements.
19. A female who is pregnant, breastfeeding, or intends to become pregnant, or a woman of childbearing potential (WOCBP) who is not using highly effective contraceptive methods.
20. Known or suspected abuse of narcotics.
21. Participant in another intervention study.
22. Vulnerable (i.e., under guardianship) or mentally incapacitated subjects (i.e., not able to understand and sign the informed consent).

Where it's running

• Steno Diabetes Center Copenhagen
  Herlev, Denmark Recruiting
• University Medical Center Hamburg-Eppendorf
  Hamburg, Germany Not yet recruiting
• Hospital Clinico de Valencia
  Valencia, Spain Not yet recruiting
• Lund University
  Malmö, Sweden Not yet recruiting

Study contacts

• Study coordinator: Peter Rossing
• Email: peter.rossing@regionh.dk
• Phone: +4530913383

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.