FLOW Trial Results Categorized by CKD Severity

The FLOW trial was designed to assess the effect of semaglutide versus placebo on the progression of renal impairment in people with type 2 diabetes and chronic kidney disease (NCT03819153). Results demonstrated an association between treatment with semaglutide and reduction in risks of major kidney outcomes, cardiovascualr events, and death from any cause in patients with type 2 diabetes and chronic kidney disease.

During an oral session at ASN Kidney Week 2024, Katherine R. Tuttle, MD, and colleagues presented results of an analysis of data from the FLOW trial assessing kidney outcomes by baseline CKD severity. The presentation was titled Semaglutide Reduced Risks of Major Kidney Outcomes Irrespective of CKD Severity in the FLOW Trial.

Eligible patients had type 2 diabetes with eGFR 50–75 mL/min/1.73 m² and UACR >300 to <5000 mg/g, or eGFR 25 to <50 mL/min/1.73 m² and UACR >100 to <5000 mg/g. Trial participants were randomized to receive semaglutide 1 mg subcutaneously once per week or placebo.

The primary outcome of interest was a composite of kidney failure (defined as eGFR <15 mL/min/1.73 m² or initiation of chronic kidney replacement therapy), ≥50% decline in eGFR, or death related to kidney or cardiovascular causes. Participants were stratified based on baseline eGFR and UACR.

Of the 3,533 study participants, 1,069 (30%) were women. Mean age at baseline was 67 years, mean eGFR was 47 mL/min/1.73 m², and median UACR was 568 mg/g. Over a median of 3.4 years, for the primary outcome of composite of kidney failure, ≥50 decline in eGFR, or kidney or cardiovascular death, the hazard ratio was 0.76 in the semaglutide group versus placebo (95% CI, 0.66-0.88). Results were consistent across categories of eGFR and UACR.

“Semaglutide safely reduced risks of major kidney outcomes irrespective of CKD severity defined by baseline eGFR or UACR in participants with type 2 diabetes and CKD in the FLOW trial,” the authors said.

Source: Tuttle KR, Mann JF, Sokareva E, et al. Semaglutide reduced risks of major kidney outcomes irrespective of CKD severity in the FLOW trial. SA-OR93. Abstract of an oral presentation at the American Society of Nephrology Kidney Week 2024; October 26, 2024; San Diego, California. Funding for the study was provided by Novo Nordisk.