Daratumumab and Belatacept for Desensitization

Completed · Phase 1/Phase 2

Conditions studied: Highly Sensitized Prospective Kidney Transplant Recipients

In brief

Some kidney transplant candidates have a very low chance of getting a kidney transplant because their immune systems are "highly sensitized" to most kidney donors. Being "highly sensitized" means that they will likely have to wait a long time (more than 5 years) before an acceptable donor is found for them or, they never receive a compatible donor, and die on waitlist. The purpose of this study is to find out whether two drugs, daratumumab (Darzalex®), and belatacept (Nulojix®), can make these kidney transplant candidates less sensitized, and make it easier and quicker to find a kidney donor for them.

Key facts

Study ID

NCT04827979

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

19

Starts

2021-11-01

Expected to finish

2026-04-02

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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 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 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.
• 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

You may not qualify if…

• 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

Where it is running

• University of California at San Francisco Medical Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.