The rationale, design and baseline data of FLOW, a kidney outcomes trial with once-weekly semaglutide in people with type 2 diabetes and chronic kidney disease

Author:

Rossing Peter12ORCID,Baeres Florian M M3,Bakris George4,Bosch-Traberg Heidrun3,Gislum Mette3,Gough Stephen C L3,Idorn Thomas3,Lawson Jack3,Mahaffey Kenneth W5,Mann Johannes F E6,Mersebach Henriette3,Perkovic Vlado7,Tuttle Katherine8,Pratley Richard9

Affiliation:

1. Complication Research, Steno Diabetes Center Copenhagen , Herlev , Denmark

2. Department of Clinical Medicine, University of Copenhagen , Copenhagen, Denmark

3. Novo Nordisk A/S , Søborg , Denmark

4. Department of Medicine, AHA Comprehensive Hypertension Center, University of Chicago Medicine , Chicago, IL , USA

5. Department of Medicine, Stanford Center for Clinical Research, Stanford School of Medicine , Palo Alto, CA , USA

6. Outpatients Clinic, KfH Kidney Center , München , Germany

7. Faculty of Medicine and Health, University of New South Wales , Sydney , NSW, Australia

8. Division of Nephrology, University of Washington/Providence Health Care , Spokane, WA , USA

9. Translational Research Institute, AdventHealth , Orlando , FL, USA

Abstract

ABSTRACT Background 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 the 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 (NCT03819153), a trial investigating the effects of semaglutide, a once-weekly (OW) GLP-1RA, on kidney outcomes in participants with CKD and T2D. Methods 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:creatinine ratio (UACR) >300‒<5000 mg/g or eGFR ≥25‒<50 ml/min/1.73 m2 and UACR >100‒<5000 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. Results Enrolled participants (N = 3534) had a baseline mean age of 66.6 years [standard deviation (SD) 9.0], haemoglobin A1c of 7.8% (SD 1.3), diabetes duration of 17.4 years (SD 9.3), eGFR of 47.0 ml/min/1.73 m2 (SD 15.2) and median UACR of 568 mg/g (range 2‒11 852). According to Kidney Disease: Improving Global Outcomes guidelines categorisation, 68.2% were at very high risk for CKD progression. Conclusion FLOW will evaluate the effect of semaglutide on kidney outcomes in participants with CKD and T2D, and is expected to be completed in late 2024.

Funder

Novo Nordisk

Publisher

Oxford University Press (OUP)

Subject

Transplantation,Nephrology

Reference43 articles.

1. Medical costs associated with type 2 diabetes complications and comorbidities;Li;Am J Manag Care,2013

2. KDIGO 2022 clinical practice guideline for diabetes management in chronic kidney disease;Kidney Disease: Improving Global Outcomes Diabetes Work Group;Kidney Int,2020

3. Standards of medical care in diabetes–2022;American Diabetes Association;Diabetes Care,2022

4. ADA/KDIGO consensus: ‘Speaking the same language’ on CKD management;McDermid

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