Belatacept Injection for Kidney Transplant
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if using belatacept (an injection) with a proteasome inhibitor can help more people find suitable kidney donors. It targets individuals who are highly HLA sensitized, meaning their bodies are likely to reject a kidney, making it difficult to find a match. Participants should currently be waiting for a kidney transplant at the University of Chicago and have been living with this challenge. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are taking investigational drugs, you must stop them at least 14 days before starting the study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that belatacept has been tested for safety in kidney transplant patients. In one study, patients who switched to belatacept had better kidney function after one year compared to those on other treatments. Another study found that after five years, 76% of patients on belatacept were still doing well. However, a virus infection can pose a risk of kidney problems, possibly requiring a change in treatment.
In this trial, belatacept is used with a proteasome inhibitor. Although specific data for this combination is not available, studies on belatacept alone indicate it can be well-tolerated by many patients. The trial is in the early stages, so researchers are closely monitoring safety. Participants will have regular check-ups for any side effects or health issues.12345Why do researchers think this study treatment might be promising?
Unlike the standard immunosuppressive therapies used for kidney transplants, like tacrolimus or cyclosporine, belatacept offers a novel approach by selectively blocking the co-stimulation of T-cells, which are crucial in the immune response that can lead to organ rejection. This targeted action may reduce the risk of chronic kidney damage and other side effects associated with long-term use of traditional immunosuppressants. Researchers are excited about belatacept because it has the potential to improve transplant outcomes by specifically decreasing the calculated Panel of Reactive Antibodies (cPRA), which could expand the pool of suitable donor kidneys for highly sensitized patients.
What evidence suggests that belatacept might be an effective treatment for kidney transplant candidates?
Research has shown that belatacept can improve outcomes for kidney transplant patients. Studies have found that belatacept significantly reduces the risk of death and loss of the transplanted kidney. For instance, one study discovered that after 7 years, a more intensive belatacept treatment reduced the risk of death by 38%. Additionally, patients using belatacept often experience better kidney function over time. In this trial, participants will receive belatacept and a proteasome inhibitor, which may help highly sensitized patients by increasing the chances of finding a suitable donor match based on a negative crossmatch.34567
Who Is on the Research Team?
Piotr Witkowski, MD PhD
Principal Investigator
University of Chicago
Are You a Good Fit for This Trial?
This trial is for highly sensitized kidney transplant candidates who are EBV IgG positive, have no active infections or allergies to the drugs being tested, and are not pregnant. They must be vaccinated against COVID-19 and hepatitis B, listed for a transplant at University of Chicago, and agree to use two contraception methods post-treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Desensitization Treatment
Highly sensitized patients are treated with belatacept and proteasome inhibitor to decrease calculated Panel of Reactive Antibodies (cPRA) and find a suitable kidney donor
Follow-up
Participants are monitored for safety and effectiveness after treatment, including episodes of Antibody Mediated Rejection (AMR) and Acute Cellular Rejection (ACR)
What Are the Treatments Tested in This Trial?
Interventions
- Belatacept
Belatacept is already approved in United States, European Union for the following indications:
- Prophylaxis of organ rejection in adult patients receiving a kidney transplant
- Prophylaxis of organ rejection in adult patients receiving a kidney transplant
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor