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

NCT07239570 | Recruiting Phase 4

• 1 other identifier: 2023-507449-27
• Study Type: interventional
• Target: 125
• Locations: 4 countries
• Sites: 4

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 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.

Conditions

Chronic Kidney Disease(CKD)

Keywords

Chronic Kidney Disease; Personalized medicine; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Chronic eGFR slope

  Mean annual rate of change in eGFR from week 26 to week 104.

  From week 26 to 104

Secondary Outcomes (3)

• Change in eGFR from baseline to end of study

  From baseline to week 112

• Change in eGFR from baseline to end of treatment.

  From baseline to week 104

• Change in UACR

  From baseline to week 104

Other Outcomes (1)

• Change in KidneyIntelX score

  From baseline to week 104

Study Arms (2)

Standard of care

NO INTERVENTION

Participants in the standard of care group will receive treatment following the KDIGO (Kidney Disease: Improving Global Outcomes) guidelines.

Biomarker-targeted treatment

EXPERIMENTAL

In the treatment arm, the participants will receive stepwise treatment with one or more study drugs. The choice, order, and number of treatments introduced will be based on the participant's characteristics/risk profile and the response on UACR and UEGF.

Drug: Dapagliflozin; Drug: Semaglutide; Drug: Finerenone

Interventions

Dapagliflozin DRUG

Dapagliflozin 10 mg daily.

Biomarker-targeted treatment

Semaglutide DRUG

Semaglutide injection once weekly. Will be titrated every 4 weeks to the highest tolerable dose according to standard guidelines, aiming at 1 mg once weekly.

Biomarker-targeted treatment

Finerenone DRUG

Finerenone 10-20 mg daily.

Biomarker-targeted treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 75 years
• 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.)
• 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.)
• Ability to communicate with the study staff and understand and sign the informed consent.

You may not qualify if:

• eGFR \< 25 mL/min/1.73m2 at screening.
• Treatment with two or all three of the study drugs
• History of pancreatitis at screening
• Body mass index \< 18.5 kg/m2 at screening
• Type 1 diabetes
• Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrollment
• NYHA class IV Congestive Heart Failure at screening
• Potassium \> 5.0 mmol/L at screening
• Addison's Disease
• Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, cobicistat, clarithromycin)
• Treatment with a potassium-sparing diuretic or a mineralocorticoid receptor antagonist, except for finerenone (e.g., spironolactone, eplerenone, or amiloride)
• 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).
• Autosomal dominant or autosomal recessive polycystic kidney disease
• Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening
• Kidney transplant or dialysis

Sponsors & Collaborators

• Peter Rossing: lead
• University Medical Center Groningen: collaborator
• Lund University: collaborator
• Instituto de Investigacion Sanitaria INCLIVA: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (4)

Steno Diabetes Center Copenhagen

Herlev, Denmark

RECRUITING

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

NOT YET RECRUITING

Hospital Clinico de Valencia

Valencia, Spain

NOT YET RECRUITING

Lund University

Malmo, Sweden

NOT YET RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

dapagliflozin; semaglutide; finerenone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Peter Rossing

CONTACT

+4530913383; peter.rossing@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, DMSc

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: November 20, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); DE (1); DK (1); ES (1)