Desensitization & Transplantation
Patients with immune systems that are “highly sensitized” have antibodies against most people (9 out of 10) who might donate a kidney for transplantation. They have to wait a long time (often more than 5 years) before a well-matched donor is found for them and have a high risk of rejection after transplant. Desensitization is a process that can lower the immune system’s sensitization to kidney donors, making it easier to find a well-matched kidney.
Participating in the Study
The ATTAIN 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 60 weeks (14 months). However, if you receive a transplant during your time in the study, you will get extra follow up for 1 year.
|
Phase |
# of Visits |
How Long Phase Lasts |
|
Screening |
2 |
4 weeks |
|
Study Treatment |
10 |
14 weeks |
|
Follow-up |
5-7 |
42-52 weeks |
|
Extended follow-up if you get a transplant during the study |
6 |
52 weeks after transplant |
You must come to the study hospital for certain visits. Some visits may be conducted by phone call. Other visits require lab work that can be done at your local laboratory. During your study visits at the hospital, you will undergo procedures including a physical exam, vital signs, and review of your health and current medications.
You will also have a total of 10 infusions of the study drugs: 6 infusions of daratumumab (Darzalex®), and 4 infusions of belatacept (Nulojix®). In addition, research samples (blood, tissue, and bone marrow cells) will be collected during this study.