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.
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.
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
Parallel
Dapagliflozin
DrugDapagliflozin 10 mg daily.
Semaglutide
DrugSemaglutide injection once weekly. Will be titrated every 4 weeks to the highest tolerable dose according to standard guidelines, aiming at 1 mg once weekly.
Finerenone
DrugFinerenone 10-20 mg daily.
Chronic eGFR slope
Mean annual rate of change in eGFR from week 26 to week 104.
Change in eGFR from baseline to end of study
Change in eGFR from baseline to week 112 (end of study).
Change in eGFR from baseline to end of treatment.
Change in eGFR from baseline to week 104 (end of treatment).
Change in UACR
Change in UACR from baseline to week 104 (end of treatment)
Change in KidneyIntelX score
Change in KidneyIntelX (kidney risk score) score from baseline to week 104 (end of treatment). An increase in the score represents an increase in predicted risk of CKD progression, and a decline represents a reduction in predicted risk.
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Peter Rossing
Lead sponsor
Steno Diabetes Center Copenhagen
Sponsor institution
University Medical Center Groningen
Collaborator
Lund University
Collaborator
Instituto de Investigacion Sanitaria INCLIVA
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator
