‣ 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 dialysis

• United Network for Organ Sharing (UNOS) listed for a kidney transplant with any one of the following:

‣ Current calculated panel reactive antibodies (cPRA) ≥ 99.9 percent awaiting deceased donor transplant

⁃ Current cPRA \>98 percent (with \>5 years of waiting time) awaiting deceased donor transplant

⁃ Current cPRA \>98 percent with Human Leukocyte Antigen (HLA)-incompatible approved living donor and has not received a transplant after 1 year in a kidney paired exchange program

• 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 tuberculosis infection (LTBI) therapy.

‣ Testing should be conducted using either a purified protein derivative (PPD) or interferon-gamma release assay (i.e. QuantiFERON-TB, T-SPOT.TB).

⁃ Negative 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 result must have completed appropriate therapy for LTBI.

• Note: LTBI treatment regimens should be among those endorsed by the Centers for Disease Control and Prevention (CDC), 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 6 months prior to screening)

• Negative Hepatitis C antibody test at screening or as documented in medical record, up to 6 months prior to screening.

⁃ -If there is a history of treated hepatitis C then documentation of two consecutive negative HCV quantitative ribonucleic acid (RNA) polymerase chain reaction (PCR) tests separated by at least 6 months is required. Untreated subjects with positive HCV antibody and a single negative HCV quantitative HCV RNA are eligible.

• Negative result for SARS-CoV-2 by an FDA-authorized molecular diagnostic test. Examples include, but are not limited to RT-PCR, LAMP, TMA, and qSTAR.

• Subjects must have an echocardiogram within the previous 1 year without any of the following findings:

‣ severe left ventricular hypertrophy (LVH)

⁃ greater than mild LVH accompanied by diastolic dysfunction

⁃ left ventricular ejection fraction \<40 percent

⁃ pulmonary hypertension defined as right ventricular systolic pressure \>35 mm Hg or tricuspid regurgitant velocity \>2.8 m/s

⁃ Female subjects of reproductive potential must have a negative pregnancy test upon study entry

⁃ All subjects of reproductive potential must agree to use contraception for the duration of the study

⁃ Subjects must have current vaccinations or documented immunity to:

∙ varicella (chickenpox)

‣ measles

‣ hepatitis B

‣ pneumococcus

‣ influenza, and

‣ varicella zoster (if ≥ 50 years old).

⁃ Note: If subjects require administration of either live or killed vaccines to meet eligibility requirements, they must wait at least 2 weeks between vaccination and the baseline visit (i.e., at least 4 weeks before initiation of therapy)

‣ Living Donor Inclusion Criteria:

‣ Living donors must meet all of the following criteria to be eligible-

• Able to understand and provide informed consent for research

• Meets United Network for Organ Sharing (UNOS) requirements for kidney organ donation