{"doi":"10.1093/ndt/gfad009","title":"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","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.","journal":"Nephrology Dialysis Transplantation","year":2023,"id":315048,"datarank":5.185051634045834,"base_score":5.480638923341991,"endowment":5.480638923341991,"self_citation_contribution":0.8220958385012987,"citation_network_contribution":4.3629557955445355,"self_endowment_contribution":0.8220958385012987,"citer_contribution":4.3629557955445355,"corpus_percentile":null,"corpus_rank":null,"citation_count":239,"citer_count":100,"citers_with_citation_signal":100,"citers_with_endowment":100,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9365,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT03819153"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1015669,"name":"Florian M.M. Baeres","orcid":null,"position":1,"is_corresponding":false},{"id":6,"name":"George L. Bakris","orcid":"0000-0003-1183-1267","position":2,"is_corresponding":false},{"id":1015670,"name":"Heidrun Bosch‐Traberg","orcid":null,"position":3,"is_corresponding":false},{"id":745481,"name":"Mette Gislum","orcid":null,"position":4,"is_corresponding":false},{"id":21572,"name":"Stephen Gough","orcid":null,"position":5,"is_corresponding":false},{"id":273070,"name":"Thomas Idorn","orcid":null,"position":6,"is_corresponding":false},{"id":1015671,"name":"Jack Lawson","orcid":null,"position":7,"is_corresponding":false},{"id":75047,"name":"Kenneth W. Mahaffey","orcid":"0000-0002-3791-2148","position":8,"is_corresponding":false},{"id":34487,"name":"Johannes F.E. Mann","orcid":"0000-0002-3154-5332","position":9,"is_corresponding":false},{"id":1015672,"name":"Henriette Mersebach","orcid":null,"position":10,"is_corresponding":false},{"id":75046,"name":"Vlado Perkovic","orcid":"0000-0002-4257-7620","position":11,"is_corresponding":false},{"id":231214,"name":"Katherine R. Tuttle","orcid":"0000-0002-2235-0103","position":12,"is_corresponding":false},{"id":1015673,"name":"Richard Pratley","orcid":null,"position":13,"is_corresponding":false},{"id":42050,"name":"Peter Rossing","orcid":"0000-0002-1531-4294","position":0,"is_corresponding":true}],"reference_count":44,"raw_metadata":null,"created_at":"2026-07-19T01:06:02.898877Z","pmid":"36651820","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}