FLOW PRIMARY RESULTS: A KIDNEY OUTCOMES TRIAL WITH ONCE-WEEKLY SEMAGLUTIDE IN PEOPLE WITH TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE
Professor VLADO PERKOVIC1
1Faculty of Medicine and Health, University of New South Wales, Sydney, Australia
Chronic kidney disease (CKD) is a common complication of type 2 diabetes (T2D). Glucagon-like peptide-1 receptor agonists (GLP-1RAs) improve glycaemic control and lower body weight in people with T2D, and some reduce risk of cardiovascular (CV) events in those with high CV risk. GLP-1RAs might also have kidney-protective effects. We report the design and baseline data for FLOW, a trial investigating the effects of once-weekly (OW) GLP-1RA semaglutide on kidney outcomes in participants with CKD and T2D.
FLOW is a randomised, double-blind, parallel-group, multinational, phase 3b trial. Participants with T2D, estimated glomerular filtration rate (eGFR) ≥50‒≤75 mL/min/1.73 m2 and urine albumin-to-creatinine ratio (UACR) >300‒<5,000 mg/g or eGFR ≥ 25‒<50 mL/min/1.73 m2 and UACR > 100‒<5,000 mg/g, were randomised 1:1 to OW semaglutide 1.0 mg or matched placebo, with renin-angiotensin-aldosterone system blockade (unless not tolerated/contraindicated). The composite primary endpoint is time to first: kidney failure (persistent eGFR <15 mL/min/1.73 m² or initiation of chronic kidney replacement therapy); persistent ≥ 50% reduction in eGFR; or death from kidney or CV causes.
Enrolled participants (N = 3 534) had a baseline mean (SD) age of 66.6 (9.0) years, HbA1c of 7.8 (1.3) %, diabetes duration of 17.4 (9.3) years, eGFR of 47.0 (15.2) mL/min/1.73 m2 and median UACR of 568 (range: 2‒11 852) mg/g. According to Kidney Disease: Improving Global Outcomes guideline categorisation, 68.2% were at very high risk for CKD progression.
FLOW will evaluate the effect of semaglutide on kidney outcomes in participants with CKD and T2D will readout 24th of May 2024 and results will be updated to this abstract.
Presentation Slides PDF – Click here
Biography:
Professor Vlado Perkovic is the Provost and Scientia Professor at the University of New South Wales in Sydney, Australia, and was previously the Dean of the Faculty of Medicine & Health at UNSW. He is a Nephrologist and a leading clinical trialist in Nephrology. His research focuses on preventing the progression of kidney disease, and its complications. He has led the Steering Committees of a large number of ground-breaking international clinical trials including FLOW, APPLAUSE, DUPLEX, PROTECT, CREDENCE, TESTING, ASCEND, CARMELINA and other, and leads several that are ongoing. He has received several international awards and is a Fellow of the Australian Academy of Health and Medical Sciences. He serves on the Editorial Board of the New England Journal of Medicine, and is a Highly Cited Researcher (Clarivate, top 0.1% of cited authors).