ADAPT is a clinical study to test whether treatment with two drugs, carfilzomib (Kyprolis®) and belatacept (Nulojix®), can reduce the number of plasma cells while you are on the kidney transplant waiting list. This process is called desensitization.
Plasma cells are immune system cells that make antibodies. Antibodies are proteins that react to foreign cells. With fewer plasma cells, your immune system might make fewer antibodies to possible kidney donors.
The goal of the ADAPT study is to find out:
- Whether using the two study drugs together is safe
- Whether using the study drugs can lower the number of antibodies you have against kidney donors
- Whether using the drugs will increase the chances that you find a ‘matching’ kidney donor
It is not known whether the study treatment will work or whether it will help you, which is why these drugs are being used in a research study. If the study treatment works and is safe, it might improve your chance of finding a ’matching’ kidney donor and reduce your risk of rejection after transplant. If not, you might be no worse off than you were before receiving the study drugs, or you might be made ill by the drugs without getting any benefit.
Participation
The ADAPT study has 3 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 up to 76 weeks (18 months). If you receive a transplant during your time in the study, you will be followed for 1 year after your transplant.
|
Phase |
# of Visits |
How Long Phase Lasts |
|
Screening and Enrollment |
2 - 4 |
Up to 12 weeks |
|
Study Treatment |
26 |
52 weeks |
|
Follow-up |
1 - 9 |
12-51 weeks |
|
Extra follow up if you get a transplant while in the study |
15 |
52 weeks after transplant |
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 receive 12 infusions of carfilzomib (Kyprolis®) and 16 doses of belatacept (Nulojix®).
Some visits will also include research collections such as additional blood. You may also have up to 3 bone marrow cell collections for research. Bone marrow is a soft tissue inside your bones where blood cells are made. The bone marrow is collected using a hollow needle usually from the back of your hip bone. 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.