PRODIG : Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early post-transplant period
A kidney transplant can give someone a fresh start, but some patients develop high blood sugar afterwards. This condition is known as new-onset diabetes after transplantation. It often happens because of the strong medicines needed to protect the new kidney. This Phase 3 trial is testing whether a tablet called vildagliptin (brand name Galvus) can stop diabetes from developing in the first place. Participants take the 50 mg tablets for a short period right after their transplant operation. Doctors will follow participants for one full year. They will test their blood sugar levels, kidney health, and general recovery at regular check-ups. They will also look at quality of life and healthcare costs. If successful, this simple treatment could help kidney transplant patients avoid diabetes and enjoy better long-term health.
At a glance
What is this study about?
Receiving a kidney transplant is a life-changing treatment for kidney failure. However, the journey does not end with surgery. Patients must take powerful medications to stop their body from rejecting the new kidney. A common side effect of these medicines is an increase in blood sugar, which can lead to a condition called post-transplant diabetes. Developing diabetes can damage blood vessels, harm the new kidney, and cause other health problems.
This clinical trial, called PRODIG, is testing a medicine called vildagliptin (Galvus 50 mg). Vildagliptin is an established tablet commonly used to help manage type 2 diabetes by helping the body produce insulin when needed. In this study, doctors want to see if giving this tablet early on—right after the transplant operation—can protect the body and prevent diabetes from developing at all.
Over the course of one year, researchers will closely track how many patients develop diabetes. They will also run regular checks to ensure the transplanted kidney remains healthy, monitor for any infections or side effects, and see how the treatment affects daily quality of life. The ultimate goal is to find a safe and simple way to keep kidney recipients healthier for longer.
Key takeaways
- The trial tests whether a tablet called vildagliptin can prevent diabetes after a kidney transplant.
- Participants take the medicine for a short time in the early weeks following transplant surgery.
- Doctors will monitor blood sugar, kidney health, and quality of life for 12 months.
- The study is for adults aged 18 and older receiving a kidney transplant.
- Joining is voluntary and will not change your standard post-transplant medical care.
Who may be eligible?
This trial is open to adults aged 18 and over who are receiving a kidney transplant. Both men and women can take part.
Because the goal is to see if the medicine stops new diabetes from starting, this study is generally meant for people who do not already have diabetes before their operation.
Your transplant care team will look at your overall medical history, your current medications, and your blood test results to confirm whether this study is safe and suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- You are aged 18 or older.
- You are scheduled for or have recently had a kidney transplant.
- You do not have a known history of diabetes before the transplant.
- You are able to take daily tablets by mouth.
- You are willing to attend follow-up visits and blood tests for one year.
What does participation involve?
If you take part, you will be asked to take vildagliptin (Galvus 50 mg) tablets by mouth for a short period in the early weeks following your kidney transplant. You will then be monitored closely by your hospital care team for a total of 12 months.
During this year, you will attend routine follow-up clinic visits at key points, such as 3 months, 6 months, and 12 months after your surgery. At these visits, doctors will test your blood sugar, check your HbA1c (a measure of average blood sugar over several months), and run routine checks on your kidney, liver, and blood counts. You will also complete short questionnaires about your quality of life at about 8 days, 3 months, 6 months, and 12 months to see how you are feeling day to day.
Potential risks and benefits
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Common questions
Why do people get diabetes after a kidney transplant?
The medicines used to stop your body from rejecting a new kidney can make it harder for your body to manage sugar, which can trigger diabetes in some people.
What is vildagliptin (Galvus)?
It is a standard tablet already approved to treat type 2 diabetes. It works by helping the pancreas produce insulin when blood sugar levels rise.
Will taking part interfere with my anti-rejection medicines?
Your transplant team will carefully monitor all your medicines together to ensure your new kidney stays safe and protected at all times.
How long do I need to take the study tablets?
You only take the tablets for a short period during the early weeks after your transplant, but your health will be tracked for a full year.
What happens if I change my mind during the study?
You are free to stop taking part at any point. Your doctors will continue to give you standard, high-quality post-transplant care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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