PREDONATION KIDNEY RESERVE: IMPACT IN THE EVOLUTION OF DONOR AND RECIPIENT RENAL FUNCTION IN A RENAL TRANSPLANTATION PROGRAMME OF LIVING DONOR
This study, called "PREDONATION KIDNEY RESERVE," is looking into living kidney donation. Its main goal is to understand how well the kidneys work in both the donor and the person who receives the new kidney, both before and after the operation. They will use a special fluid called Nephrotect during the transplant process to see if it helps protect the donated kidney. Researchers will also measure kidney function using an accurate test involving a substance called iohexol, and they will assess 'kidney reserve' by giving an amino acid solution. This is a Phase III study, meaning it's a key step to confirm if this treatment is effective and safe. It's open to adults aged 18 and over, both men and women.
At a glance
What is this study about?
This research study is focused on people involved in living kidney donation. When someone donates a kidney while they are still alive, medical teams want to make sure both the donor and the person receiving the kidney stay as healthy as possible. This study is specifically looking at how well the kidneys work over time for both people involved.
Researchers will use a special liquid called Nephrotect during the kidney transplant. They want to find out if this liquid helps to protect the donated kidney, which could lead to better long-term results for both the donor and the recipient. They will carefully measure kidney function using specific tests, including one that uses a substance called iohexol for accurate results. They will also look at something called 'kidney reserve,' which is how much extra capacity your kidneys have to work, by giving a special amino acid solution.
This is a 'Phase III' study, which means it’s a very important step to confirm if the ideas being tested are truly effective and safe. The information gathered from this study could help improve the care and outcomes for everyone involved in living kidney donation in the future.
Key takeaways
- This study is for adults involved in living kidney donation.
- It aims to understand how well kidneys work before and after transplant.
- A special solution called Nephrotect will be used to see if it protects the donated kidney.
- Researchers will use detailed tests to measure kidney function and 'kidney reserve'.
- Findings could improve future care for kidney donors and recipients.
Who may be eligible?
To be part of this study, you need to be an adult, meaning you must be 18 years old or older. There is no upper age limit, so people of all adult ages can take part.
Both men and women are welcome to participate in this research. The study needs to include a wide range of people to understand the effects of the treatment fully.
The specific details of whether you are a kidney donor or a kidney recipient, and other health conditions, will be discussed by the study team. They will check to make sure the study is a good fit for your individual situation.
- Are you 18 years old or older?
- Are you a man or a woman?
- Are you either a kidney donor or someone receiving a kidney from a living donor?
- Are you comfortable with extra tests to measure kidney function?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would undergo specific assessments to measure your kidney function both before and after the kidney transplant. These measurements will use a standard test involving a substance called iohexol, which helps doctors accurately see how well your kidneys are working. You would also have a test to see your 'kidney reserve,' which involves a small intravenous drip of an amino acid solution.
The study will involve monitoring your kidney health for a period after the transplant. This means you would have regular check-ups and tests. The special solution, Nephrotect, would be used during the transplant procedure itself. The total duration of your participation would involve the transplant procedure and follow-up appointments to track your kidney health over time, but the exact number of visits and the full length of the follow-up would be explained by the study team.
Potential risks and benefits
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Common questions
What is 'kidney reserve'?
Kidney reserve is your kidneys' ability to work harder when needed, like when you have a lot of protein to process. This study will measure how much extra function your kidneys have.
What is Nephrotect?
Nephrotect is a special solution that will be given during the kidney transplant. Researchers want to see if it helps protect the donated kidney and makes it work better for longer.
What does 'Phase III' mean for this study?
Phase III means this is an important and often the final step before a treatment might become widely available. Doctors are trying to confirm if the treatment is both safe and effective on a larger group of people.
Will I have extra tests if I join?
Yes, you would likely have specific tests to measure your kidney function, including one using a substance called iohexol, and an assessment of your kidney reserve using an amino acid solution.
Do I have to pay to be in this study?
Clinical trials are typically free for participants, and often cover the costs of study-related care. It’s important to clarify any financial aspects with the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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