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Daratumumab plus belatacept desensitization trial (ATTAIN)

Principal Investigator

Flavio G. Vincenti, MD | University of California, San Francisco Medical Center

Locations

University of California, San Francisco Medical Center | San Francisco, CA

Study Code

ITN090ST

Study Status

Active

Abstract

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.

Highly sensitized patients whose immune systems are much more likely to react against donated organs could have to wait a very long time to find a donor kidney that their immune system will accept. 

Since plasma cells make antibodies, ATTAIN will investigate whether using daratumumab (Darzalex®) and belatacept (Nulojix®) together can lower the number of plasma cells in “highly sensitized” people on the kidney transplant waiting list. With fewer plasma cells, fewer antibodies to kidney donor cells might be made. This would improve the chances of finding a "matching" donor and reduce the risk of rejection after transplant. 

Participants will have a total of 10 infusions of the study drugs: 6 infusions of daratumumab, and 4 infusions of belatacept. Research samples (blood, tissue, and bone marrow cells) will be collected during this study.

Study participation will last 60 weeks (14 months). If the participant receives a transplant during their time in the study, there will be 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 transplant is received during the study

6

52 weeks after transplant

About This Study

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.

[Clinicaltrials.gov] [Study Website]

Do you Qualify for this Clinical Trial?

You may be eligible to participate in the ATTAIN study if you:

  • Are 18 years of age or older
  • Have end stage renal disease
  • Are on the wait list for a kidney transplant
  • Have a high level of antibodies in your system that react to potential donors

In total, your participation may last between 14 and 26 months.

Principal Investigator

Flavio G. Vincenti, MD | University of California, San Francisco Medical Center

Locations

University of California, San Francisco Medical Center | San Francisco, CA

The Immune Tolerance Network and is sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

National Institute of Allergy and Infectious Diseases

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