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