A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: kidney
- Who it enrolls
- age 18 Years to 75 Years; excludes diabetes; no BMI minimum stated; conditions: Chronic Kidney Disease(CKD)
- Interventions
- Dapagliflozin; Semaglutide; Finerenone
- Conditions
- Chronic Kidney Disease(CKD)
- Phase and size
- Phase 4 · 125 participants
- Dates
- Start 2025-06-20
Primary completion 2028-06 - Sponsor
- Peter Rossing (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Chronic eGFR slopeFrom week 26 to 104
02Eligibility
Who can take part
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).
03Change log
Registry changes
No changes recorded since the trial was added.