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Semaglutide for Type 2 Diabetes with Chronic Kidney Disease (REMODEL Trial)
REMODEL Trial Summary
This trial is testing if semaglutide can help fight chronic kidney disease in people with type 2 diabetes. Participants will be randomly assigned to receive either semaglutide or placebo, and will be monitored for a year through clinic visits and phone calls. Blood and urine samples will be taken, and participants will also have MRI scans.
REMODEL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowREMODEL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 104 Patients • NCT04189848REMODEL Trial Design
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- I haven't taken any strong anti-inflammatory or immunosuppressant drugs in the last 3 months, except for aspirin for my heart or occasional ibuprofen.I haven't had a heart attack, stroke, or severe heart issues in the last 6 months.I have been on a stable dose of ACE inhibitor or ARB for at least 28 days.You have had an organ transplant in the past, or you are waiting to have an organ transplant.I am 18 years old or older.I was diagnosed with type 2 diabetes more than 6 months ago.I have a genetic or autoimmune kidney disease, like polycystic kidney disease or glomerulonephritis.My kidney function, measured by eGFR, is between 40 and 75 mL/min.My kidney function, measured by eGFR, is between 30 and 75 mL/min.I have been on a stable dose of ACE inhibitor or ARB for at least 28 days.I do not have unstable diabetic eye problems verified by a recent eye exam.My kidney function, measured by eGFR, is between 30 and 75 mL/min.You are unable to have a MRI scan due to reasons like claustrophobia, metal implants, or certain types of tattoos.I was diagnosed with type 2 diabetes more than 6 months ago.I am taking both an ACE inhibitor and an ARB medication.I am either male or female.Your HbA1c level is no more than 9.0 percent (75 mmol/mol).I have not used any GLP-1 receptor agonists in the last 30 days.Your UACR test result is between 20 and 5000 mg/g.I am either male or female.Your HbA1c level is 9.0 percent or lower.I haven't had cancer, except for certain skin, cervical, or prostate cancers, in the last 5 years.Your HbA1c level is 9.0 percent or lower (75 mmol/mol or lower).I am either male or female.I am 18 years old or older.Your HbA1c level is 9.0 percent or lower.I was diagnosed with type 2 diabetes more than 6 months ago.Your UACR test shows a level of albumin in your urine that is between 20 and 5000 mg/g.My kidney function, measured by eGFR, is between 30 and 75 mL/min.
- Group 1: Semaglutide 1.0 mg OW
- Group 2: Placebo (Semaglutide) 1.0 mg OW
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has a study like this ever been done before?
"Semaglutide has had a long journey to market, with the first clinical trial being performed in 2018. However, after Phase 4 drug approval was received in late 2018, 59 active trials for Semaglutide have cropped up across 766 cities and 55 countries."
Did the FDA sign off on Semaglutide?
"Despite being a Phase 3 trial, there is already some data suggesting semaglutide's efficacy. Furthermore, the medication has gone through multiple rounds of testing for safety, so it received a score of 3 from our team."
How many people are being included in this clinical trial?
"The clinical trial is currently ongoing, as reflected by the information available on clinicaltrials.gov. This specific study was posted on 4/28/2021 and last updated 5/27/2022. There are 105 participants enrolled at 7 different sites."
In how many different places is this trial taking place?
"Currently, there are 7 sites where patients can enroll in this study. The locations of these centres are San Dimas, Aurora, Toronto and 4 other undisclosed cities. If you wish to participate in this trial, it might be best to select a site that is close to your home to reduce travel time and costs."
Are we still able to include new test subjects in this research?
"That is correct, the online information shows that this research project is still recruiting people. The trial was first advertised on April 28th 2021 and updated as recently as May 27th 2022. There are 7 sites for this study and they are looking to enroll 105 patients in total."
What is the primary goal of this experiment?
"The primary goal of this 52-week clinical trial is to observe the change in kidney inflammation via MRI T1 mapping. Additionally, researchers will be measuring the ADC in the medulla, glomerular basement membrane width, and mean arterial flow as secondary objectives."
What is the primary indication for Semaglutide?
"Semaglutide is most often used as a weight management tool for obese patients, but it can also help those with other conditions like type 2 diabetes who are following a calorie-restricted diet and exercising regularly."
Could you provide context for Semaglutide's efficacy by referencing other clinical trials?
"Semaglutide was first researched in 2018 at the Novo Nordisk Investigational Site. As of now, 124 studies have been completed with 59 more ongoing. The majority of these live trials are based in Toronto, Canada."
Who else is applying?
What state do they live in?
How old are they?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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What questions have other patients asked about this trial?
How responsive is this trial?
Typically responds via
Average response time
- < 2 Days
Most responsive sites:
- Novo Nordisk Investigational Site: < 48 hours
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