Stuart Knechtle | Duke University School of Medicine | Durham, NC
Duke Transplant | Durham, NC
ITN089ST
Enrollment
ADAPT is a clinical study to learn whether a new treatment plan can increase the chances for highly sensitized kidney transplant candidates to find a kidney donor match.
The goal of the ADAPT study is to study whether using two drugs, carfilzomib (Kyprolis®) and belatacept (Nulojix®), together can lower the number of plasma cells in “highly sensitized” people on the kidney transplant waiting list.
Before you get a kidney transplant, doctors run tests to find out if your immune system will react against potential kidney donors. If those tests show that you are “highly sensitized,” meaning your immune system will react against the donated organs of most people (9 out of 10), then it might take a very long time to find a donor kidney that your immune system will accept. Also, having a more reactive immune system makes it more likely that your body will reject the transplant.
Plasma cells are immune system cells that make antibodies. Antibodies are proteins that recognize foreign cells and signal that an immune response should occur. With fewer plasma cells, your immune system might make fewer antibodies to kidney donor cells. This could improve your chance of finding a “matching” kidney donor and reduce your risk of rejection after transplant.
We do not know whether you or anyone participating in this study will make fewer antibodies or be more likely to get a transplant.
The ADAPT study has 4 phases as outlined in the table below. Your visit schedule will depend on the phase of the study and how well you are doing. In total, your participation will last 78 weeks (18 months). However, if you receive a transplant during your time in the study, you will get extra follow up for 1 year.
You must come to the study hospital for all visits. In between some visits, you may be required to have lab work that can be done at your local laboratory. During your study visits, you will generally get a brief physical exam, a review of your health and current medications, and blood tests.
You will also have a total of 12 infusions of carfilzomib and 16 doses of belatacept. Research samples (blood, tissue, and bone marrow cells) will be collected during this study. In addition, if you have a transplant while on this study, 1-2 lymph nodes will be taken during the transplant surgery. The lymph nodes will be taken only if they are readily available.
You may be eligible to participate in the ATTAIN study if you:
In total, your participation may last between 18 and 30 months.
