Clinical Impact of the IBox As an Early Intervention TooL
This study is investigating a new tool called Predigraft for people who have received a kidney transplant. When someone gets a new kidney, doctors need to keep a close eye on it to make sure it's working well and isn't being rejected by the body. This study wants to find out if using Predigraft can help doctors detect potential issues with the transplanted kidney earlier than current methods. If problems are found sooner, doctors might be able to make changes to treatment more quickly, which could lead to better overall health and longer life for both the new kidney and the patient. It's a large study involving many hospitals internationally, comparing Predigraft use to standard care.
At a glance
What is this study about?
When you have a kidney transplant, it's really important for doctors to monitor your new kidney closely. Sometimes, the body can try to reject the new organ, or other problems might come up. Finding these issues early can help doctors give you the right treatment to keep your kidney working well for as long as possible.
This study is looking at a new monitoring tool called Predigraft. Imagine it like a more advanced way for doctors to keep an eye on your transplanted kidney. The researchers believe that by using Predigraft, doctors might be able to spot problems sooner, even before you feel unwell.
The main goal is to see if using Predigraft leads to doctors taking biopsies (small tissue samples) at an earlier stage when they notice something might be wrong. If these biopsies lead to changes in your treatment, then it suggests that Predigraft is helping doctors act more quickly. Ultimately, the hope is that this earlier detection and treatment will help your transplanted kidney last longer and improve your overall health and survival.
Key takeaways
- The study assesses a new tool, Predigraft, for monitoring transplanted kidneys.
- The goal is to help doctors find and treat kidney issues earlier.
- It could lead to better long-term health for transplant patients.
- It's a comparison study: Predigraft vs. standard care.
- Participation is voluntary and you can withdraw at any time.
Who may be eligible?
To be part of this study, you need to be at least 18 years old. You must have received a kidney transplant from either a living or deceased donor. It's also important that your transplant happened at least three months before you join the study.
Before you start, you'll need to read and sign a consent form, which explains everything about the study. You should also be willing to follow the study's instructions and attend any necessary appointments.
However, some people won't be able to join. This includes if you've had a combined transplant (for example, a heart and kidney transplant at the same time). You also can't take part if you're already in another study involving new treatments, or if you're unable or unwilling to follow the study procedures. The study also cannot include minors or anyone legally unable to consent for themselves.
- Are you 18 years old or older?
- Have you had a kidney transplant (not combined with another organ)?
- Was your kidney transplant at least 3 months ago?
- Are you able and willing to follow study instructions?
- Are you not currently in another medical trial that involves new treatments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
This study is designed to fit into your existing follow-up care for your kidney transplant. It's an international study, meaning many hospitals around the world are taking part. You would be randomly assigned to either receive care that includes the Predigraft tool or to continue with the standard care your doctor already provides. This random assignment is like flipping a coin – it helps make sure the study results are fair and accurate. The study will involve regular check-ups and monitoring, similar to what you already have, but for some, this will include the use of Predigraft to help your doctors make decisions. The exact duration of your participation would be discussed with you, but it aims to monitor your long-term kidney health.
Potential risks and benefits
Locations (16)
- Medizinische Universität InnsbruckInnsbruck, Austria
- Hôpital Saint-LouisParis, France
- Hôpital TenonParis, France
- CHU RangueilToulouse, France
- Hôpital NeckerParis, France
- Universitätsklinikum Düsseldorf AÖRDüsseldorf, Germany
- Universitätsklinikum Hamburg-EppendorfHamburg, Germany
- Sourasky Medical Center - Ichilov HospitalTel Aviv, Israel
- Hospital Del Mar - Parc de Salut MarBarcelona, Spain
- Fundació PuigvertBarcelona, Spain
- Hospital Universitari i Politècnic La FeValencia, Spain
- Queen Elizabeth HospitalBirmingham, United Kingdom
+4 more sites — see the official record for the full list.
Common questions
What is Predigraft?
Predigraft is a new tool that doctors can use to monitor your transplanted kidney more closely and potentially detect problems earlier.
Will I definitely get Predigraft if I join?
No, you will be randomly assigned to either receive care with the Predigraft tool or continue with standard medical care. It's like a fair coin toss.
What does 'biopsy leading to therapeutic change' mean?
It means taking a small sample of your kidney tissue because the monitoring suggested a problem, and the biopsy results then led to your doctor changing your treatment plan.
How long will I be in the study?
The study aims to improve long-term kidney health, so your participation duration would be discussed with you and would fit into your ongoing transplant follow-up.
Can I leave the study at any time?
Yes, you are completely free to leave the study at any point without it affecting your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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