A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease

Last updated: November 18, 2025
Sponsor: Peter Rossing
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Dapagliflozin

Semaglutide

Finerenone

Clinical Study ID

NCT07239570
2023-507449-27
  • Ages 18-75
  • All Genders

Study 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 contacts, and hospitalizations, but also outstanding costs for the health system and the solidarity community. Appropriate interventions are essential to prevent the development and progression of CKD. In the past decade, great progress has been made in the search for drugs that can slow the progression of CKD. Sodium-glucose co-transporter 2 inhibitors, the non-steroidal mineralocorticoid receptor antagonist, finerenone, and the glucagon-like peptide-1 receptor agonist, semaglutide, have demonstrated albuminuria-lowering effects and kidney protection in people with CKD. Although these new pharmacological approaches show great promise, it is unclear how to optimally sequence and combine these therapies. In addition, the therapies are often not implemented due to treatment inertia and fear of adverse effects. This study aims to address this knowledge gap by utilizing a biomarker-guided treatment approach to reduce the decline in kidney function.

The aim of the CKD-bioMatch study is to evaluate the efficacy of a biomarker-targeted treatment approach versus standard of care in people with CKD and albuminuria. We hypothesize that a biomarker-targeted treatment approach is superior to standard of care at reducing estimated glomerular filtration rate (eGFR) decline in people with CKD.

Eligibility Criteria

Inclusion

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 urinesamples at screening. (UACR 80-100 mg/g is accepted if historical measurements areabove 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 enzymeinhibitor or angiotensin receptor blocker for at least four weeks prior torandomization. (Unless such treatment is contraindicated or not tolerated.)

  4. Ability to communicate with the study staff and understand and sign the informedconsent.

Exclusion

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 receptorantagonist, 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 toa history of hepatic encephalopathy, a history of esophageal varices, or a historyof portocaval shunt).

  13. Autosomal dominant or autosomal recessive polycystic kidney disease

  14. Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondarykidney disease requiring immunosuppressive therapy within 6 months prior toscreening

  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 orsquamous cell skin cancer) within five years before screening.

  18. Any other history, condition, therapy, or uncontrolled intercurrent illness thatcould, as judged by the investigator, affect participant safety or compliance withstudy requirements.

  19. A female who is pregnant, breastfeeding, or intends to become pregnant, or a womanof childbearing potential (WOCBP) who is not using highly effective contraceptivemethods.

  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., notable to understand and sign the informed consent).

Study Design

Total Participants: 125
Treatment Group(s): 3
Primary Treatment: Dapagliflozin
Phase: 4
Study Start date:
June 20, 2025
Estimated Completion Date:
June 30, 2028

Study 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 will be randomized 1:1 to a biomarker-targeted treatment approach versus standard of care.

In the treatment arm, a sequence of pharmacological treatments will be added (dapagliflozin, finerenone, and/or semaglutide), guided by the participant's characteristics and the urinary biomarkers urinary albumin-to-creatinine ratio (UACR) and urinary epidermal growth factor (UEGF). Participants will start treatment with one of the three study medications. After approximately four weeks on the maximum tolerated dose of the allocated medication, UACR and UEGF will be measured, and based on the biomarker response, a decision will be made to continue, switch, or add a new treatment. If a second drug is initiated, the treatment effect of that second drug will be evaluated on UACR and UEGF after four weeks on the maximum tolerated dose, and if the UACR response is insufficient, a third drug can be added, or the third drug can replace the second drug. The biomarker response of the third drug will be evaluated in the same manner as that of the first two drugs.

Connect with a study center

  • Steno Diabetes Center Copenhagen

    Herlev 2620431,
    Denmark

    Active - Recruiting

  • University Medical Center Hamburg-Eppendorf

    Hamburg 2911298,
    Germany

    Site Not Available

  • Hospital Clinico de Valencia

    Valencia 2509954,
    Spain

    Site Not Available

  • Lund University

    Malmo 2692969,
    Sweden

    Site Not Available

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