LivingGLP1
Study S000395

Renal Mode of Action of Semaglutide in Patients With Type 2 Diabetes and Chronic Kidney Disease

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

Registration

Registration
NCT04865770
Acronym
REMODEL
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
QUADRUPLE
Status
COMPLETED
Enrollment
106
Start
2021-04-28
Primary completion
2024-11-21
Lead sponsor
Novo Nordisk A/S
Conditions
Diabetes Mellitus, Type 2; Chronic Kidney Disease
Interventions
DRUG:Semaglutide; DRUG:Placebo (Semaglutide)
Results posted
TRUE
Individual participant data sharing
YES
Secondary identifiers
OTHER:U1111-1248-7912; EUDRACT_NUMBER:2020-000828-19

Registered primary outcomes

  • Change in Kidney Oxygenation (Cortex), Blood Oxygenation-level Dependent Magnetic Resonance Imaging (BOLD MRI) (R2*) [Baseline (week 0), End of treatment (week 52)]
  • Change in Kidney Oxygenation (Medulla), BOLD MRI (R2*) [Baseline (week 0), End of treatment (week 52)]
  • Change in Global Kidney Perfusion (MRI) [Baseline (week 0), End of treatment (week 52)]
  • Change in Kidney Inflammation (Cortex), Longitudinal Relaxation Time (T1) Mapping (MRI) [Baseline (week 0), End of treatment (week 52)]
  • Change in Kidney Inflammation (Medulla), T1 Mapping (MRI) [Baseline (week 0), End of treatment (week 52)]

Linked records (9)

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:NCT04865770; registry reference DERIVED:41207620
R0007381Effects of semaglutide on kidney disease in type 2 diabetes: a randomized placebo-controlled trial.
Tuttle KR, Nature medicine
2026Randomized trialPMID 42823485DOIcites ClinicalTrials.gov:NCT04865770; registry reference DERIVED:42823485
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:NCT04865770; registry reference DERIVED:39480988
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:NCT04865770; registry reference DERIVED:39963952
R0012807Rationale, design and baseline characteristics of REMODEL, a mechanism-of-action trial with semaglutide in people with type 2 diabetes and chronic kidney disease.
Cherney DZI, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
2025ProtocolPMID 40608494DOIcites ClinicalTrials.gov:NCT04865770
R0003419The glucagon-like peptide-1 receptor agonist semaglutide in diabetic kidney disease: A new kid on the block to afford maximal kidney protection.
Georgianos PI, European journal of clinical investigation
2024Randomized trialPMID 38979836DOIcites ClinicalTrials.gov:NCT04865770
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:NCT04865770
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:NCT04865770
R0051826MO399: Remodel: A Mechanistic Trial Evaluating the Effects of Semaglutide on the Kidneys In People With Type 2 Diabetes and Chronic Kidney Disease
Petter Bjornstad, Nephrology Dialysis Transplantation
2022Nonrandomized studyDOIcites ClinicalTrials.gov:NCT04865770