Daratumumab and Belatacept for Desensitization (NCT04827979) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Daratumumab and Belatacept for Desensitization
United States19 participantsStarted 2021-11-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects who have not met a subject stopping rule and remain free of all of the safety events listed in the outcome description, through 26 weeks after starting treatment or until receiving a transplant, whichever occurs earlier
Timeframe: Baseline up to 26 weeks post treatment initiation
2
Proportion of subjects who meet any one of the pre-specified events detailed in the outcome description: from Baseline up to Week 26 - Cohort 1
Timeframe: Baseline (Visit 0) up to 26 weeks post treatment initiation
3
Proportion of subjects who meet any one of the pre-specified events detailed in the outcome description: from Baseline up to Week 26 - Cohort 2
Timeframe: Baseline (Visit 0) up to 52 weeks post treatment initiation
Trial details
NCT IDNCT04827979
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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
Exclusion criteria
. 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