Status:
RECRUITING
A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease
Lead Sponsor:
Peter Rossing
Collaborating Sponsors:
University Medical Center Groningen
Lund University
Conditions:
Chronic Kidney Disease(CKD)
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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 c...
Detailed Description
The study is a prospective, randomized, open-label, parallel-group, multicenter study. CKD-bioMatch will enroll 125 individuals with CKD (eGFR ≥ 25 mL/min/1.73m² and UACR 100-5000 mg/g). Participants ...
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 and ≤ 75 years
- 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.)
- 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.)
- Ability to communicate with the study staff and understand and sign the informed consent.
Exclusion Criteria:
- eGFR < 25 mL/min/1.73m2 at screening.
- Treatment with two or all three of the study drugs
- History of pancreatitis at screening
- Body mass index < 18.5 kg/m2 at screening
- Type 1 diabetes
- Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrollment
- NYHA class IV Congestive Heart Failure at screening
- Potassium > 5.0 mmol/L at screening
- Addison's Disease
- Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, cobicistat, clarithromycin)
- 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).
- Autosomal dominant or autosomal recessive polycystic kidney disease
- 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
- 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.
- 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.
- 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).
Key Trial Info
Start Date :
June 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT07239570
Start Date
June 20 2025
End Date
June 1 2028
Last Update
November 20 2025
Active Locations (4)
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1
Steno Diabetes Center Copenhagen
Herlev, Denmark
2
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
3
Hospital Clinico de Valencia
Valencia, Spain
4
Lund University
Malmo, Sweden