LivingGLP1
Study S000953

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

Included trial: extracted dataClinicalTrials.gov recordStudy Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration
NCT03819153
Acronym
FLOW
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
QUADRUPLE
Status
COMPLETED
Enrollment
3533
Start
2019-06-17
Primary completion
2024-01-09
Lead sponsor
Novo Nordisk A/S
Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG:Semaglutide; DRUG:Placebo (semaglutide)
Results posted
TRUE
Individual participant data sharing
YES
Secondary identifiers
OTHER:U1111-1217-6259; REGISTRY:2018-002878-50; REGISTRY:JapicCTI-194843; NIH:2018

Registered primary outcomes

  • Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death [From Week 0 up to Week 234]

Linked records (29)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0004202REMODELing mechanistic trials for kidney disease: a multimodal, tissue-centered approach to understand the renal mechanism of action of semaglutide.
Pruijm M, Kidney international
2026ProtocolPMID 41207620DOIcites ClinicalTrials.gov:NCT03819153; registry reference DERIVED:41207620
R0013411Effect of semaglutide on COVID-19 and other infections: an analysis from the FLOW randomized clinical trial.
Rayner B, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
2026Randomized trialPMID 41728915DOIcites ClinicalTrials.gov:NCT03819153; registry reference DERIVED:41728915
R0015191Kidney and Survival Benefits of Semaglutide in Diabetes With Chronic Kidney Disease: FLOW Trial Cardiovascular Subgroup Analyses.
Tuttle KR, Journal of the American College of Cardiology
2026Randomized trialPMID 42233552DOIcites ClinicalTrials.gov:NCT03819153; registry reference DERIVED:42233552
R0015402Kidney and Survival Outcomes with Semaglutide by CKD Severity in the FLOW Trial.
Tuttle KR, Clinical journal of the American Society of Nephrology : CJASN
2026Randomized trialPMID 41706532DOIcites ClinicalTrials.gov:NCT03819153; registry reference DERIVED:41706532
R0018814Prevalence and Associations of Systemic Inflammation in Heart Failure Across the Spectrum of Ejection Fraction.
Borlaug BA, JACC. Heart failure
2026OtherPMID 41099689DOIcites ClinicalTrials.gov:NCT03819153
R0002391The Impact of Glucagon-Like Peptide-1 Receptor Agonists on Kidney Outcomes: A Meta-Analysis of Randomized Placebo-Controlled Trials.
Mendonça L, Clinical journal of the American Society of Nephrology : CJASN
2025Systematic reviewPMID 39480988DOIcites ClinicalTrials.gov:NCT03819153; registry reference DERIVED:39480988
R0005138Once-weekly semaglutide versus placebo for the treatment of type 2 diabetes and chronic kidney disease in Denmark: A long-term cost-effectiveness analysis based on FLOW.
Rossing P, Cardiovascular diabetology
2025Nonrandomized studyPMID 41422027DOIcites ClinicalTrials.gov:NCT03819153; registry reference DERIVED:41422027
R0010237Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
Natale P, The Cochrane database of systematic reviews
2025Systematic reviewPMID 39963952DOIcites ClinicalTrials.gov:NCT03819153; registry reference DERIVED:39963952
R0048629Effect of Semaglutide on Hemoglobin A1c and Body Weight Change by CKD Stage: Post Hoc Analysis from the FLOW Trial
Allon N. Friedman, Journal of the American Society of Nephrology
2025Randomized trialDOIcites ClinicalTrials.gov:NCT03819153
R0055469Kidney, Cardiovascular, and Death Outcomes with Semaglutide Treatment Among Two Race and Two Ethnic Groups: Post Hoc Analysis from the FLOW Trial
Christian W. Mende, Journal of the American Society of Nephrology
2025Other trialDOIcites ClinicalTrials.gov:NCT03819153
R0006943Effects of semaglutide with and without concomitant SGLT2 inhibitor use in participants with type 2 diabetes and chronic kidney disease in the FLOW trial.
Mann JFE, Nature medicine
2024Randomized trialPMID 38914124DOIcites ClinicalTrials.gov:NCT03819153; registry reference DERIVED:38914124
R0007867Effects of Semaglutide on Heart Failure Outcomes in Diabetes and Chronic Kidney Disease in the FLOW Trial.
Pratley RE, Journal of the American College of Cardiology
2024Randomized trialPMID 39217553DOIcites ClinicalTrials.gov:NCT03819153; registry reference DERIVED:39217553
R0019043Response to "Experience with dulaglutide in an obese diabetic patient on incremental peritoneal dialysis". Response to related letter.
De La Flor JC, Nefrologia
2024CommentaryPMID 38862303DOIcites ClinicalTrials.gov:NCT03819153; registry reference DERIVED:38862303
R0019192Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials.
Kosiborod MN, Lancet (London, England)
2024Randomized trialPMID 39222642DOIcites ClinicalTrials.gov:NCT03819153; registry reference DERIVED:39222642
R0019647Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes.
Perkovic V, The New England journal of medicine
2024Randomized trialPMID 38785209DOIcites ClinicalTrials.gov:NCT03819153; registry reference DERIVED:38785209
R0020853FLOW trial stopped early due to evidence of renal protection with semaglutide.
Gragnano F, European heart journal. Cardiovascular pharmacotherapy
2024Randomized trialPMID 37934595DOIcites ClinicalTrials.gov:NCT03819153
R0049482Use of SGLT2 Inhibitors and Glucagon-Like Peptide 1 (GLP-1) Receptor Agonists in Australian Primary Care Patients with Type 2 Diabetes Mellitus (T2DM) Stratified by CKD Status
Hannah Wallace, Journal of the American Society of Nephrology
2024Nonrandomized studyDOIcites ClinicalTrials.gov:NCT03819153
R0006475The 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.
Rossing P, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
2023ProtocolPMID 36651820DOIcites ClinicalTrials.gov:NCT03819153; registry reference BACKGROUND:36651820
R0007476Glucagon-like peptide-1 receptor agonists in diabetic kidney disease: A review of their kidney and heart protection.
Michos ED, American journal of preventive cardiology
2023Other trialPMID 37313358DOIcites ClinicalTrials.gov:NCT03819153
R0050208Prevalence of systemic inflammation in individuals with atherosclerotic cardiovascular disease: baseline characteristics from the SELECT, SOUL and FLOW phase 3 trials of semaglutide
Nikolaus Marx, European Heart Journal
2023Randomized trialDOIcites ClinicalTrials.gov:NCT03819153
R0052122Proportion of patients with systemic inflammation and their characteristics for groups at high cardiovascular risk in phase 3 randomized placebo-controlled trials of semaglutide (SELECT, SOUL, FLOW)
John Eric Deanfield, European Heart Journal
2023Randomized trialDOIcites ClinicalTrials.gov:NCT03819153
R0016965The Role of Glucagon-Like Peptide 1 (GLP-1) Receptor Agonists in the Prevention and Treatment of Diabetic Kidney Disease: Insights from the AMPLITUDE-O Trial.
Tommerdahl KL, Clinical journal of the American Society of Nephrology : CJASN
2022Randomized trialPMID 35396319DOIcites ClinicalTrials.gov:NCT03819153
R0022257Mineralocorticoid Receptor Antagonists in the Treatment of Diabetic Kidney Disease: Their Application in the Era of SGLT2 Inhibitors and GLP-1 Receptor Agonists.
Cohen S, Current diabetes reports
2022Randomized trialPMID 35441935DOIcites ClinicalTrials.gov:NCT03819153; registry reference DERIVED:35441935
R0028935Obesity in CKD: A Promising Path Forward.
Friedman AN, Clinical journal of the American Society of Nephrology : CJASN
2022Randomized trialPMID 36126996DOIcites ClinicalTrials.gov:NCT03819153
R0049234Baseline cardiovascular risk in subjects with type 2 diabetes and chronic kidney disease from the FLOW trial
Kenneth W. Mahaffey, European Heart Journal
2022Randomized trialDOIcites ClinicalTrials.gov:NCT03819153
R0052456FC 123: Baseline Characteristics of the Flow Trial Population: Kidney Outcomes Trial With Once-Weekly Semaglutide in People With Type 2 Diabetes and Chronic Kidney Disease
Vlado Perkovic, Nephrology Dialysis Transplantation
2022Randomized trialDOIcites ClinicalTrials.gov:NCT03819153
R0054131The foundation and the four pillars of treatment for cardiorenal protection in people with chronic kidney disease and type 2 diabetes
Rajiv Agarwal, Nephrology Dialysis Transplantation
2022Randomized trialPMID 36535638DOIcites ClinicalTrials.gov:NCT03819153
R0054682747-P: Baseline Characteristics of Subjects in the Once-Weekly (OW) Semaglutide FLOW Kidney Outcomes Trial
Richard E. Pratley, Diabetes
2022Randomized trialDOIcites ClinicalTrials.gov:NCT03819153
R0050752MO051EFFECTS OF SEMAGLUTIDE ON CHRONIC KIDNEY DISEASE OUTCOMES: A POST HOC POOLED ANALYSIS FROM THE SUSTAIN 6 AND PIONEER 6 TRIALS
Katherine R. Tuttle, Nephrology Dialysis Transplantation
2020Nonrandomized studyDOIcites ClinicalTrials.gov:NCT03819153