The FLOW study: Effects of Semaglutide on chronic kidney disease in patients with type 2 diabetes

Global Kidney Trials Insights: A guide for Everyone

The FLOW study: Effects of Semaglutide on chronic kidney disease in patients with type 2 diabetes

Global Kidney Trials Insights: A Guide for Everyone

1. The question for investigation?

Semaglutide (Ozempic) is supposedly effective in managing blood sugar levels. It works well as a treatment for diabetes and causes weight loss. It also protects people with diabetes from heart disease.

The FLOW trial asks the question: Does semaglutide also protect the kidneys in people with diabetes and kidney disease?

Chronic kidney disease (CKD) affects one in ten people worldwide. People with CKD are also at high risk for associated problems like cardiovascular events (heart attacks, strokes, and heart failure), kidney failure and death. The FLOW study tested the effectiveness and safety of semaglutide (Ozempic) at a dose of 1.0 mg weekly in people with type 2 diabetes and CKD. The study was done at 387 sites in 28 countries and included 3533 people who were randomly assigned to semaglutide or placebo. The study would specifically determine if the newly developed medicine was superior and helped in managing diabetes with better results than other medications available to the target population.

2. The findings of the study

Semaglutide was found to have better outcomes. The rate of deaths from cardiovascular events was 24% lower than in the placebo group, major cardiovascular events were 18% lower, and deaths from any cause were 20% lower. They also found that the kidneys were better maintained with semaglutide. There was a slower yearly decline eGFR levels (1.16 ml/min/1.73 m2 lower in the semaglutide group). There were also fewer serious adverse events (side effects or other problems) in the semaglutide group than in the placebo group (49.6% vs. 53.8%). In this study, semaglutide safeguarded against cardiovascular complications and led to slower progression in kidney disease in patients with type 2 diabetes and chronic kidney disease. The study provides hope for better treatment options for the many people challenged by kidney disease due to diabetes. We look forward to future studies that will test if semaglutide also helps people with CKD who do not have diabetes, or if it is helpful for people with new-onset diabetes after transplantation.

This edition was edited by Brendan Smyth, ISN-ACT Committee member and Vasundhara Raghavan, member of the Patient Liaison Advisory Group, supported by members of the ISN Patient Engagement in Renal Trials subgroup and members of the Patient Liaison Advisory Group.

Glossaries

Read the GTF editorial team’s review of the FLOW trial here.
Access the complete study here.
Any questions? Contact us at research@theisn.org

Glossaries

Adrenal glands are small glands that sit on top of the kidneys.

Efficacy refers to how well a medication or treatment works in achieving its intended effect.

Aldosterone is a hormone produced by your adrenal glands, which sit on top of your kidneys. It's kind of like a chemical messenger that helps regulate the amount of water and salt in your body.

Semaglutide is a medication used to treat type 2 diabetes and help with weight loss. It works by mimicking a hormone (called GLP-1) in the body that helps control blood sugar and appetite. It's usually given as an injection.

Random assignment (or randomisation) is a way of putting people into different groups in a study by chance, like flipping a coin. This helps make sure the groups are similar at the start of the study, so researchers can better tell if a treatment is really working.

Cardiovascular disease refers to diseases that affect the heart and blood vessels. This includes problems like heart attacks, strokes, and heart failure. Diabetes, high cholesterol, high blood pressure, and being overweight can damage the blood vessels and cause cardiovascular disease.

refers to the best way to take care of patients

refers to an event over time that is measured to monitor the impact of a treatment in a given population.

Delayed graft function happens when a transplanted kidney does not start working right away and needs additional support with dialysis to help remove excess fluid and waste from the blood, Delayed graft function can be linked to several problems, including the need for ongoing dialysis until the kidney works well enough, longer hospital stays, a higher risk of kidney failure, and death.

This contains the electrolytes commonly found in our bodies. It has extra minerals like potassium and magnesium that are important to help keep our bodies healthy.

It contains primarily salty water. It is commonly used during and early after the transplant surgery; and

Arteriovenous fistula (AVF): irregular connection between an artery and a vein

Hemodiafiltration, is combining this process with direct fluid removal by adding many tiny holes, also called pores, to the membrane. These pores allow fluid and waste to be passed through more easily, including larger wastes that might not otherwise be removed through dialysis. As this process involves much more fluid being removed, some replacement waste-free fluid is added to the filtered blood before it returns to the body. It is unclear if this approach improves heart health and survival. 

In hemodialysis, wastes are removed from the blood by travelling through a barrier (called a membrane) in the filter of the dialysis machine, which allows wastes to pass through but aims to keep important parts of the blood, like blood cells and protein, in the bloodstream. One challenge of this approach is that some larger wastes (called middle-molecular-weight molecules), do not pass through the barrier very well. The build-up of these wastes may increase the risk of health problems, including for heart health.