Daratumumab and Belatacept for Desensitization

Inclusion Criteria:

Individuals who meet all of the following criteria are eligible for enrollment as study subjects-

Subject must be able to understand and provide informed consent
End stage renal disease (ESRD) on hemodialysis

United Network for Organ Sharing (UNOS) listed listed with current calculated panel reactive antibodies (cPRA) ≥99.9% or >98% (with >5 years of waiting time) awaiting deceased donor transplant

--Note: Those with cPRA >98% with human leukocyte antigen (HLA)-incompatible approved living donor who have not received a transplant after 1 year in a paired kidney exchange program are also eligible

Evidence of established immunity to Epstein-Barr Virus (EBV) as demonstrated by serologic testing

Negative result of most recent tuberculosis (TB) testing or appropriately completed latent TB infection (LTBI) therapy.

Testing should be conducted using either a PPD or interferon-gamma release assay (i.e., QuantiFERON-TB, T-SPOT.TB)
Results from tests performed within 12 months prior to study entry are acceptable in the absence of any intervening exposure to TB
Subjects with a positive test for LTBI must complete appropriate therapy for LTBI ---LTBI treatment regimens should be among those endorsed by the Centers for

Disease Control and Prevention (CDC), Division of TB Elimination, url:

https://www.cdc.gov/tb/topic/treatment/ltbi.htm

Negative Food and Drug Administration (FDA)-approved test for human immunodeficiency virus (HIV) diagnosis (at screening or as documented in medical record, up to 12 months prior to screening)

Negative Hepatitis C antibody test at screening or as documented in medical record, up to 12 months prior to screening

--If there is a history of treated hepatitis C or there is a suspected false positive hepatitis C virus (HCV) antibody test, then documentation of two consecutive negative HCV quantitative ribonucleic acid (RNA) Polymerase chain reaction (PCR) tests separated by at least 6 months is required

Negative result for 2019-novel Coronavirus (2019-nCoV) by real-time reverse transcriptase (RT-PCR)
Female subjects of reproductive potential must have a negative pregnancy test upon study entry
All subjects of reproductive potential must agree to use of contraception for the duration of the study

Subjects must have current vaccinations or documented immunity to varicella, measles, hepatitis B, pneumococcus, influenza, and zoster (if ≥50 years old)

If subjects require administration of vaccines to meet eligibility requirements, they must wait at least 2 weeks between vaccination and the baseline (Visit 0) visit

Exclusion Criteria:

Individuals who meet any of these criteria are not eligible for enrollment as study subjects-

Inability or unwillingness of a subject to give written informed consent or comply with study protocol
Known active current or history of invasive fungal infection or non-tuberculous mycobacterial infection
Hepatitis B surface antigen or core antibody positive
Serious uncontrolled concomitant major organ disease excluding kidney failure
Previous non-kidney solid organ or bone marrow transplant
Any infection requiring hospitalization and intravenous (IV) antibiotics within 4 weeks of screening or by mouth (PO) antibiotics within 2 weeks
Primary or secondary immunodeficiency
History of active tuberculosis (TB), even if treated
History of positive result for 2019-novel Coronavirus (2019-nCoV) by real-time reverse transcriptase (RT-PCR)
Malignancy within the last 5 years except treated basal and squamous cell cancer of the skin or treated in situ cervical cancer
History of plasma cell dyscrasia
Alcohol, drug, or chemical abuse within 1 year
Difficult peripheral venous access
Need for uninterrupted anticoagulation
Neutropenia (absolute neutrophil count <1000/uL) or thrombocytopenia (platelet count <100,000/uL) within 4 weeks prior to study enrollment
Women who are currently pregnant or nursing
Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of screening
Current treatment with other biological drug
Immunization with live vaccine within 2 weeks of study baseline (Visit 0) visit

Past or current medical problems or findings from physical examination or laboratory testing not listed above, which, in the opinion of the investigator, may:

pose additional risks from participation in the study,
interfere with the subject's ability to comply with study requirements, or
impact the quality or interpretation of the data obtained from the study