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CKD-bioMatch

RecruitingPhase 4

A 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

Peter Rossing

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

NCT IDNCT07239570
Org study ID2023-507449-27

Timeline

Milestones

Study start2025-06-20actual
Study first posted2025-11-20actual
Last update posted2025-11-20actual
Primary completion2028-06estimated (month precision)
Study completion2028-06estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Chronic kidney disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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 endpoints
Primary/protocol endpoint

Chronic eGFR slope

Time frame:From week 26 to 104

eGFR slope (chronic)

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Change in UACR

Time frame:From baseline to week 104

uACR, change

change from baseline, improvement

LOINC 9318-7

Other/protocol endpoint

Change in KidneyIntelX score

Time frame:From baseline to week 104

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.