CKD-bioMatch: A biomarker-targeted clinical trial to optimize treatment for patients with chronic kidney disease
Key facts
- Where
- Bologna és Naples, OlaszországSee the 2 sites
- Phase
- 4. fázis
Where in Olaszország
- IRCCS Azienda Ospedaliero-Universitaria di BolognaBologna, OlaszországTaking people
- Azienda Ospedaliera Universitaria Luigi VanvitelliNaples, OlaszországTaking 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?
Trial details
- Who runs it
- Steno Diabetes Center Copenhagen
- Trial code
- EU 2023-507449-27-01
- Record updated
- 2026. október 14.
- 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.