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CKD-bioMatch
RecruitingPhase 4A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease
A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease: A Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study
Lead sponsor
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
4
Recruiting sites
1
Enrollment
125
estimated
Study population
Chronic kidney disease
Key I/E criterion
•UACR 100-5000
Primary endpoint
•EGFR slope (chronic)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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).
Endpoints (5)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Renal / kidney
5 endpointsChronic eGFR slope
Time frame:From week 26 to 104
eGFR slope (chronic)
change from baseline, improvement
LOINC 98979-8
Change in eGFR from baseline to end of study
Time frame:From baseline to week 112
eGFR, change
change from baseline, improvement
LOINC 98979-8
Change in eGFR from baseline to end of treatment.
Time frame:From baseline to week 104
eGFR, change
change from baseline, improvement
LOINC 98979-8
Change in UACR
Time frame:From baseline to week 104
uACR, change
change from baseline, improvement
LOINC 9318-7
Change in KidneyIntelX score
Time frame:From baseline to week 104
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.