Testing a biomarker-guided treatment approach in adults with chronic kidney disease
Compares biomarker-guided treatment with standard care in adults with chronic kidney disease.
Plain-language title generated from the registry record
Registry title: CKD-bioMatch: A biomarker-targeted clinical trial to optimize treatment for patients with chronic kidney disease
Key facts
- Where
- Herlev, DenmarkSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with chronic kidney disease and protein in the urine, who are already on a stable ACE inhibitor or ARB.
- Age
- 18 to 75 years
- Sex
- All sexes
- Disease stage
- Chronic kidney disease with UACR 100-5000 mg/g in two consecutive first-morning urine samples. UACR 80-100 mg/g can count if past results were above 100 mg/g.
- Earlier treatment
- Stable treatment with the maximum tolerated dose of an ACE inhibitor or ARB for at least four weeks before randomization, unless it is contraindicated or not tolerated.
Main reasons for not taking part
- eGFR < 25 mL/min/1.73m2 at screening
- Kidney transplant or dialysis
- Polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis
- Type 1 diabetes
- Pregnant or breastfeeding women, or women who intend to become pregnant
Read by machine on 9 November 2026.
Where in Denmark
- Steno Diabetes Center CopenhagenHerlev, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- Steno Diabetes Center Copenhagen
- Trial code
- EU 2023-507449-27-01
- Record updated
- 14 October 2026
- Original description
To compare the effect of a biomarker-targeted treatment approach versus standard of care on chronic eGFR slope.Read full original descriptionShow less
A biomarker-targeted clinical trial to optimize treatment for patients with chronic kidney disease
To compare the effect of a biomarker-targeted treatment approach versus standard of care on chronic eGFR slope.
Inclusion: Age ≥ 18 and ≤ 75 years; UACR 100-5000 mg/g (11.3-565 mg/mmol) in two consecutive first-morning void urine samples. (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.); 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 such treatment is contraindicated or not tolerated.); Ability to communicate with the study staff and understand and sign the informed consent.
Exclusion: Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, cobicistat, clarithromycin); Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening; Kidney transplant or dialysis; Treatment with two or all of the three study drugs; Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrolment; Autosomal dominant or autosomal recessive polycystic kidney disease; Known or suspected hypersensitivity to the study medications or related products; Presence or history of malignant neoplasms (except basal cell skin cancer or squamous cell skin cancer) within five years before screening; Any other history, condition, therapy, or uncontrolled intercurrent illness that could, as judged by the investigator, affect participant safety or compliance with study requirements; History of pancreatitis at screening; Type 1 diabetes; NYHA class IV Congestive Heart Failure at screening; Addison’s Disease; eGFR < 25 mL/min/1.73m2 at screening (FOR ITALY ONLY: eGFR < 30 and eGFR > 60 mL/min/1.73m2 at screening.); Treatment with a potassium-sparing diuretic or a mineralocorticoid receptor antagonist, except for finerenone (e.g., spironolactone, eplerenone, or amiloride); 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.); Serum potassium > 5.0 mmol/L at screening; A female who is pregnant, breastfeeding, or intends to become pregnant, or women of childbearing potential (WOCBP) who are not using highly effective contraceptive methods; Known or suspected abuse of narcotics; Participant in another intervention study; Vulnerable (i.e. under guardianship) or mentally incapacitated subjects (i.e. not able to understand and sign the informed consent); Body mass index < 18.5 kg/m2 at screening.