A Proof of Concept Study Non-Randomized, Single-Center Pilot Trial Assessing The Safety/Efficacy Of Dual Targeting Of Peripheral And Central Humoral Alloimmune Memory With Anti-CD38 (Daratumumab) And Costimulation Blockade With CTLA4-Ig (Belatacept) In Highly HLA-Sensitized Patients Awaiting Kidney Transplantation
This study is for adults who are waiting for a kidney transplant and have a high chance of their body rejecting a new kidney from most donors. These are often people who have been on the waiting list for a long time without finding a suitable match. The study is testing a new approach using two existing medications, Daratumumab and Belatacept. Researchers want to see if these medicines can help calm down the body's strong immune reaction, making it more likely for these patients to receive a successful transplant. It's an early-stage study to check the safety and how well this new combination works.
At a glance
What is this study about?
This study is looking into a new way to help people who are waiting for a kidney transplant, especially those who have a very strong immune system response to many potential kidney donors. Think of your immune system as your body's protector – it's good at fighting off infections, but sometimes it can be too good, making it hard to accept a new organ.
In this study, doctors are investigating two medicines together. One medicine, Daratumumab, aims to reduce certain types of immune cells that are involved in this strong reaction. The other medicine, Belatacept, works to stop your immune system from starting a strong attack against the new kidney. By using these two medicines together, the researchers hope to make it easier for people with a very active immune system to receive a kidney transplant.
The main goal of this particular study is to see if this combination of medicines is safe for patients and if it starts to show benefits in helping them find a suitable kidney. It's an early-stage study, meaning doctors are carefully checking for any side effects and how well the treatment works before it can be used more widely. Finding out if this approach works could open up new possibilities for many people still waiting for a life-changing kidney transplant.
Key takeaways
- This study explores a new treatment for hard-to-match kidney transplant patients.
- It tests two medicines to calm the immune system's strong response.
- The goal is to help patients receive a transplant safely and successfully.
- This is an early-stage study to check safety and initial effectiveness.
- Participation involves medical visits and monitoring.
Who may be eligible?
This study is looking for adult patients who are currently on the waiting list for a deceased donor kidney transplant.
You might be suitable if your body has a very strong reaction to many different potential kidney donors. This is often measured by something called cPRA or TGI, and for this study, it needs to be 95% or higher. This means it's very difficult for doctors to find a matching kidney for you. Also, you must have been on the transplant waiting list for at least one year without being offered a kidney that is 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.
- Are you 18 years old or older?
- Are you on the deceased donor kidney transplant waiting list?
- Do you have a very strong immune response (a high cPRA or TGI score, usually 95% or more)?
- Have you been on the waiting list for at least one year without a suitable kidney offer?
What does participation involve?
We don't have all the specific details about what taking part involves from the information provided. However, generally in a study like this, you would likely have a series of hospital visits for health check-ups and to receive the study medications. You would also have blood tests and other assessments to monitor your health and how the treatment is working. Once you receive a transplant, there would be follow-up appointments to check on your recovery and the transplanted kidney. The total duration of your participation would be explained to you by the study team.
Potential risks and benefits
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Common questions
What is the main goal of this study?
To see if combining two medicines can help people with very active immune systems receive a kidney transplant more easily and safely.
Who is this study for?
Adults on the kidney transplant waiting list who have a strong immune response to many donors and have been waiting for at least a year.
What kind of medicines are being tested?
The study uses two existing medicines, Daratumumab and Belatacept, that work to calm down the body's immune reaction.
Is this a new treatment?
Yes, it's a new approach combining these two specific medicines for this purpose in kidney transplant patients.
What if I change my mind about participating?
You can leave the study at any time without it affecting your 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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