CKD-bioMatch: A biomarker-targeted clinical trial to optimize treatment for patients with chronic kidney disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Steno Diabetes Center Copenhagen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Trial duration

20 Jun 2025 → ongoing

Decision date (initial)

2025-04-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Horizon Europe (Grant agreement ID: 101095146)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To compare the effect of a biomarker-targeted treatment approach versus standard of care on chronic eGFR slope.

Secondary objectives 5

1. To compare the effect of a biomarker-targeted treatment approach versus standard of care on change in eGFR from baseline to end of study.
2. To compare the effect of a biomarker-targeted treatment approach versus standard of care on change in eGFR from baseline to end of treatment.
3. To compare the effect of a biomarker-targeted treatment approach versus standard of care on albuminuria.
4. To compare the effect of a biomarker-targeted treatment approach versus standard of care on KidneyIntelX score (a validated and guideline-endorsed kidney risk score).
5. FOR ITALY ONLY: To evaluate whether UEGF can serve as a marker of therapeutic response and to explore its relationship with changes in albuminuria.

Conditions and MedDRA coding

Chronic kidney disease

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

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. (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 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 22

1. eGFR < 25 mL/min/1.73m2 at screening (FOR ITALY ONLY: eGFR < 30 and eGFR > 60 mL/min/1.73m2 at screening.)
2. Treatment with two or all of the three 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 enrolment
7. NYHA class IV Congestive Heart Failure at screening
8. Serum 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 women of childbearing potential (WOCBP) who are 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

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Chronic eGFR slope, defined as mean annual rate of change in eGFR from week 26 to week 104.

Secondary endpoints 5

1. Change in eGFR from baseline to week 112 (end of study).
2. Change in eGFR from baseline to week 104 (end of treatment).
3. Change in albuminuria from baseline to week 104.
4. Change in KidneyIntelX score from baseline to week 104.
5. FOR ITALY ONLY: Change in UEGF from baseline to week 26 and association between change in uEGF and change in albuminuria (Exploratory endpoint)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Steno Diabetes Center Copenhagen

Sponsor organisation

Steno Diabetes Center Copenhagen

Address

Borgmester Ib Juuls Vej 83

City

Herlev

Postcode

2730

Country

Denmark

Scientific contact point

Organisation

Steno Diabetes Center Copenhagen

Contact name

Peter Rossing

Public contact point

Organisation

Steno Diabetes Center Copenhagen

Contact name

Peter Rossing

Third parties 1

Locations

5 EU/EEA countries · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 38 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications