Daratumumab plus belatacept desensitization trial (ATTAIN)

ATTAIN is a clinical trial to learn whether a new drug treatment plan can increase the chances for a highly sensitized kidney transplant candidate to find a well-matched kidney donor.

The goal of ATTAIN is to study whether using two drugs, Darzalex® and Nulojix®, together can lower the number of plasma cells in “highly sensitized” people on the kidney transplant waiting list.

Highly Sensitized Kidney Transplant Recipients

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.

ATTAIN and your Plasma Cells

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.

Participating in ATTAIN

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.