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NCT04865770 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Diabetes Mellitus, Type 2 and Chronic Kidney Disease, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
- 20
- Study locations
NCT04865770: Completed Phase 3 study of Diabetes Mellitus, Type 2 and Chronic Kidney Disease, sponsored by Novo Nordisk A/S.
NCT04865770 is a Phase 3 study of Diabetes Mellitus, Type 2 and Chronic Kidney Disease that has completed, run by Novo Nordisk A/S. The registered enrollment target is 106 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04865770, a Phase 3 study of Diabetes Mellitus, Type 2 and Chronic Kidney Disease, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
- 20
- Study locations
Study Summary
We are doing this study to learn more about how semaglutide may help fight chronic kidney disease in people with type 2 diabetes. We are doing this by looking into how semaglutide works in the kidneys. Participants will either get semaglutide or placebo (a 'dummy' medicine) - which treatment participants get is decided by chance. Semaglutide is a medicine doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine into the skin once a week. The study will last for about 1 year. Participants will have 11 visits to the clinic, and 2 phone visits. Some of the visits could be in different locations. Study staff will take blood samples at most of these visits. At 9 visits, participants will be asked to bring a sample of their first morning urine. At 4 of the visits participants will have to bring urine that they have collected over the last 24 hours. The study includes magnetic resonance imaging (MRI) scans of participants' kidneys which is a test that shows a detailed picture of organs and other parts inside the body. The scan will last for 30 minutes, and is free of radiation.
Primary Outcome
Change in kidney oxygenation in cortex assessed by BOLD (blood oxygenation level dependent) MRI from baseline (week 0) to end of treatment (week 52) is presented. R2\* is a measure used in BOLD MRI to indicate the level of tissue oxygenation. A higher R2\* value means lower tissue oxygenation while a lower R2\* value means higher tissue oxygenation.
Conditions Studied
Interventions
- DRUG Semaglutide
- DRUG Placebo (Semaglutide)
Study Locations (20)
Texas
- Prolato Clinical Research Cntr - Houston
- Sun Research Institute - San Antonio
- NE Clin Res of San Antonio - San Antonio
- University of Texas San Antonio - San Antonio
California
- Academic Medical Research Institute - Los Angeles
- Roderick A. Comunale II MD Inc. - National City
- N America Res Inst - San Dimas - San Dimas
Georgia
- Atlanta Diabetes Associates - Atlanta
- Emory University Hsptl - Atlanta - Atlanta
Illinois
- Endeavor Health Glenbook Hosp - Evanston
- North Suburban Nephrology LLC - Gurnee
Washington
- Univ of Washington Med Ctr - Seattle
- Providence Medical Research Center - Spokane
Arizona
- University of Arizona-CaTs - Tucson
Colorado
- UC Anschutz Medical Campus - Aurora
Florida
- Advent Health-Res Inst - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2021-04-28 |
| Est. Completion | 2024-11-21 |
| Phase | Phase 3 |
What the finished NCT04865770 record still lists
NCT04865770 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Semaglutide is the first listed.
NCT04865770 names 20 study sites across 12 states, led by Texas, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04865770 about?
NCT04865770 is a clinical study titled "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)". We are doing this study to learn more about how semaglutide may help fight chronic kidney disease in people with type 2 diabetes. We are doing this by looking into how semaglutide works in the kidneys. Participants will either get semaglutide or placebo (a 'dummy' medicine) - which treatment partic...
What is the current status of trial NCT04865770?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2021-04-28. Estimated completion is 2024-11-21.
What conditions does trial NCT04865770 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Chronic Kidney Disease.
What interventions are being tested in trial NCT04865770?
The interventions under investigation include: Semaglutide (DRUG), Placebo (Semaglutide) (DRUG).
Who is sponsoring clinical trial NCT04865770?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04865770 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04865770's enrollment target sits among peer trials
106 197th of 348 higher than 152 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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