Diabetes may lead to a loss of kidney function. The FAME 2 Kidney trial is testing if a once daily blood fat lowering tablet can slow kidney disease progression in adults with type 2 diabetes.
Who can participate?
You may be eligible for this trial if you:
- are aged over 18 years
- have been diagnosed with type 2 diabetes and moderate kidney damage.
Where is the FAME 2 Kidney trial being conducted in Australia?
The Baker Heart and Diabetes Institute is one of 7 sites around Australia that are participating in the FAME 2 Kidney trial. Other sites are in Sydney, Melbourne, Perth and Canberra.
What is involved?
If you are interested in participating, you will need to complete a screening visit to determine if you are eligible for this trial. This appointment will occur at the FAME 2 Kidney participating site or hospital/clinic that you usually attend for your diabetes care.
If you take part in this project, you will likely be in it for about 3 1/2 years and involve a minimum of 11 clinic visits. The clinic visits are ideally planned to occur at the same time as your regular visits to your diabetes clinic or doctor. You will be asked to take one tablet daily and we will closely monitor the health of your kidneys whilst you are participating in the trial.
By taking part, you will help the researchers and other doctors and nurses around the world understand more about kidney damage with type 2 diabetes and specifically if a once daily fenofibrate tablet can slow kidney damage and other related complications. This knowledge may help many people in the future.
Frequently asked questions
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This study is testing whether a tablet called fenofibrate can help slow kidney damage in people with type 2 diabetes. It may also reduce other diabetes-related complications like eye damage, foot problems, and heart disease.
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Kidney disease is common in people with type 2 diabetes and can lead to worsening kidney function. Fenofibrate is a low-cost medicine that may help protect the kidneys, but more research is needed to confirm this.
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You may be eligible if you have type 2 diabetes and moderate kidney damage (called stage 3 chronic kidney disease).
The study team will check if you meet all the criteria.
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You’ll take one tablet daily for about 3.5 years. You’ll attend regular study visits — some in person and some by phone — to check your health, give blood and urine samples, and complete short questionnaires.
On this study you will be randomly allocated to take either the study medication or a placebo tablet (a look-alike tablet with no active ingredient). There is also the option for you to allow your blood and urine samples to be stored for future research.
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No.
This is a double-blind study, meaning neither you nor your doctor will know if you’re taking fenofibrate or a placebo. This helps us compare the effects fairly.
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No.
Joining the study is completely voluntary. You can say yes or no, and your decision won’t affect your regular medical care.
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Yes.
You can withdraw at any time, for any reason. You don’t have to give a reason, and it won’t affect your treatment or relationship with your doctors.
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Most people tolerate fenofibrate well. Some may have mild stomach upset, muscle soreness or mild elevations in liver enzymes (called AST and ALT). Typically these changes return to normal within weeks to months after stopping the drug.
Very rare side effects include gallstones, skin rash and pancreatitis. We’ll monitor your health closely throughout the study for any side effects. Should any side effects occur, appropriate notification will be given to your healthcare team and you will be given the appropriate care and monitoring.
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Yes.
Even if you choose not to allow your samples to be stored for future research, you’ll still need to provide blood and urine samples during the study to measure kidney function and protein levels in your urine. These tests are essential to the main study.
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You won’t be paid, but you may be reimbursed for reasonable costs like parking or meals if you attend a fasting visit.
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Your doctor will discuss your health and treatment options with you. Fenofibrate won’t be provided after the study, but it may be available through your usual care if needed.