Evidence map›Paper›PMID 36651820›Full record

ArticleNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2023

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.

Peter Rossing, Florian M M Baeres, George Bakris, Heidrun Bosch-Traberg, Mette Gislum, Stephen C L Gough, Thomas Idorn, Jack Lawson, Kenneth W Mahaffey, Johannes F E Mann and 4 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It reports registered trial NCT03819153. Cited by 108 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
108citing papers in PubMed, 3 pooled it
45.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03819153 phase3completed

Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease

Ran2019Enrolled3,533Registered outcomes22Posted comparisons1ConditionsDiabetes Mellitus, Type 2ArmsPlacebo (semaglutide), semaglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

108 citing papers in PubMed, 3 syntheses or guidelines pooled it, 227 citations in OpenAlex.

  1. Pooled it
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  7. Effect of semaglutide on kidney function across different levels of baseline HbA1c, blood pressure, body weight and albuminuria in SUSTAIN 6 and PIONEER 6.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
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  14. Kidney and Survival Outcomes with Semaglutide by CKD Severity in the FLOW Trial.Clinical journal of the American Society of Nephrology : CJASN · 2026
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  20. Observational

48 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 7 institutions in 3 countries.

Peter RossingComplication Research, Steno Diabetes Center Copenhagen, Herlev, Denmark.ORCID 0000-0002-1531-4294
Florian M M BaeresNovo Nordisk A/S, Søborg, Denmark.
George BakrisDepartment of Medicine, AHA Comprehensive Hypertension Center, University of Chicago Medicine, Chicago, IL, USA.
Heidrun Bosch-TrabergNovo Nordisk A/S, Søborg, Denmark.
Mette GislumNovo Nordisk A/S, Søborg, Denmark.
Stephen C L GoughNovo Nordisk A/S, Søborg, Denmark.
Thomas IdornNovo Nordisk A/S, Søborg, Denmark.
Jack LawsonNovo Nordisk A/S, Søborg, Denmark.
Kenneth W MahaffeyDepartment of Medicine, Stanford Center for Clinical Research, Stanford School of Medicine, Palo Alto, CA, USA.
Johannes F E MannOutpatients Clinic, KfH Kidney Center, München, Germany.
Henriette MersebachNovo Nordisk A/S, Søborg, Denmark.
Vlado PerkovicFaculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia.
Katherine TuttleDivision of Nephrology, University of Washington/Providence Health Care, Spokane, WA, USA.
Richard PratleyTranslational Research Institute, AdventHealth, Orlando, FL, USA.
Novo Nordisk (Denmark) · DKAdventHealth Orlando · USStanford Medicine · USUniversity of Chicago · USUniversity of Copenhagen · DKUniversity of Washington · USUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic 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.

methodsFLOW 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.

resultsEnrolled 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.

conclusionFLOW will evaluate the effect of semaglutide on kidney outcomes in participants with CKD and T2D, and is expected to be completed in late 2024.

Indexed as

Diabetes Mellitus, Type 2Renal Insufficiency, ChronicAgedClinical Trials, Phase III as TopicGlucagon-Like PeptidesHumansHypoglycemic AgentsKidneyRandomized Controlled Trials as TopicSemaglutideGlucagon-Like PeptidesHypoglycemic AgentsSemaglutidealbuminuriacardiovascular diseasediabetic kidney diseaseglomerular filtration rateglucagon-like peptide-1 receptor agonist

Identifiers

PMID36651820
PMCPMC10469096
OpenAlexW4317213523

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.