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Clinical Trial Details

Trial ID: L1064
Source ID: NCT04865770
Associated Drug: Semaglutide
Title: A Research Study to Find Out How Semaglutide Works in the Kidneys Compared to Placebo, in People With Type 2 Diabetes and Chronic Kidney Disease (the REMODEL Trial)
Acronym: REMODEL
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Chronic Kidney Disease
Interventions: DRUG: Semaglutide|DRUG: Placebo (Semaglutide)
Outcome Measures: Primary: Change in kidney oxygenation (cortex), BOLD (blood oxygenation-level dependent) MRI ( magnetic resonance imaging ), ratio, From baseline (week 0) to end of treatment (week 52)|Change in kidney oxygenation (medulla), BOLD MRI(R2), ratio, From baseline (week 0) to end of treatment (week 52)|Change in global kidney perfusion (MRI), ratio, From baseline (week 0) to end of treatment (week 52)|Change in kidney inflammation (cortex), T1 mapping (MRI), ratio, From baseline (week 0) to end of treatment (week 52)|Change in kidney inflammation (medulla), T1 mapping (MRI), ratio, From baseline (week 0) to end of treatment (week 52) | Secondary: Change in gene expression assessed by single nucleus RNA sequencing (kidney biopsy), log2 fold-change, From baseline (week 0) to end of treatment (week 52)|Change in glomerular basement membrane width (kidney biopsy), nm, From baseline (week 0) to end of treatment (week 52)|Change in ADC (apparent diffusion coefficient) (cortex) (MRI), ratio, From baseline (week 0) to end of treatment (week 52)|Change in ADC (medulla) (MRI), ratio, From baseline (week 0) to end of treatment (week 52|Change in mean RARI (renal artery resistive index ) (MRI), ratio, From baseline (week 0) to end of treatment (week 52)|Change in mean arterial flow (MRI), ratio, From baseline (week 0) to end of treatment (week 52)|Change in natriuresis (urinary sodium excretion) (urinalysis), mmol/l, From baseline (week 0) to end of treatment (week 52)|Change in albumin excretion rate (urinalysis), mg/24 hours, From baseline (week 0) to end of treatment (week 52)|Change in kidney function (creatinine clearance) (urinalysis, ml/min/1.73 m\^2, From baseline (week 0) to end of treatment (week 52
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 106
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-04-28
Completion Date: 2024-11-21
Results First Posted:
Last Update Posted: 2025-04-09
Locations: Academic Medical Research Institute, Los Angeles, California, 90022, United States|N America Res Inst - San Dimas, San Dimas, California, 91773, United States|UC Anschutz Medical Campus, Aurora, Colorado, 80045, United States|Advent Health-Res Inst, Orlando, Florida, 32804, United States|Clinical Research Consultants, LLC, Kansas City, Missouri, 64111, United States|Prolato Clinical Research Cntr, Houston, Texas, 77054, United States|NE Clin Res of San Antonio, San Antonio, Texas, 78233, United States|Univ of Washington Med Ctr, Seattle, Washington, 98195, United States|Providence Medical Research Center, Spokane, Washington, 99204, United States|UHN-Toronto General Hospital, Toronto, Ontario, M5G 2N2, Canada|Nefrologisk Klinik P 2132, Copenhagen, 2100, Denmark|Steno Diabetes Center Copenhagen, Herlev, 2730, Denmark|Centre Hospitalier Universitaire Amiens Picardie-Site Sud, AMIENS cedex 1, 80054, France|Centre Hospitalier Universitaire de Rouen - Hopital de Bois Guillaume, Bois-Guillaume, 76230, France|Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-2, Grenoble - Cédex 09, 38043, France|Centre Hospitalier Universitaire Reims-Hopital Maison Blanche, Reims, 51092, France|Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1, Toulouse, 31059, France|Istituto Scientifico San Raffaele, Milano, MI, 20132, Italy|Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, 24127, Italy|Azienda Ospedaliera di Padova Clin.Med.3, Padova, 35128, Italy|Azienda Ospedaliero - Universitaria Sant'Andrea, Roma, 00189, Italy|Centrum Medyczne "Diabetika", Radom, 26-600, Poland|SPSK nr 2 PUM, Kl. Nefrologii, Transplantologii i Ch. Wewn., Szczecin, 70-111, Poland|Miedzyleski Szpital Specjalistyczny, Oddzial Nefrologiczny, Warszawa, 04-749, Poland|Prywatny Gabinet Janusz Gumprecht, Zabrze, 41-800, Poland|Maxwell Centre, Durban, KwaZulu-Natal, 4001, South Africa|Precise Clinical Solutions (Pty) Ltd, Durban, KwaZulu-Natal, 4092, South Africa|Prof Rayner_Division of Nephrology, Cape Town, Western Cape, 7925, South Africa|Hospital Vall d'Hebron, Barcelona, 08035, Spain|Hospital de Bellvitge, Hospitalet de Llobregat, 08907, Spain|Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain
URL: https://clinicaltrials.gov/show/NCT04865770