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:

  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).

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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Page 1 of 1 (4 locations)

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