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Highly Sensitized Prospective Kidney Transplant RecipientsPhase 1/2ATTAINNCT04827979

Daratumumab and Belatacept for Desensitization

A Phase 1/2 study testing daratumumab, belatacept and Bone marrow aspiration in people with Highly Sensitized Prospective Kidney Transplant Recipients, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
daratumumab, belatacept and Bone marrow aspiration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
1 Nov 2021to 10 Sep 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California at San Francisco Medical Center

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: A Mechanistically Driven Therapy to Desensitize >98.0% cPRA Patients: Depletion of Plasma Cells With Anti-CD38 and Prevention of B Cell Activation With Costimulation Blockade (ITN090ST)

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.

Read the detailed description

This study will enroll 15 eligible adult participants with end stage renal failure on dialysis who are on the waiting list for a deceased donor transplant with calculated panel reactive antibodies (cPRA) ≥99.9% or >98% (with >5 years of waiting time) or, those with cPRA >98% and an human leukocyte antigen (HLA)-incompatible approved living donor who have not received a transplant after 1 year in a paired kidney exchange program. The study will evaluate whether the study treatment is safe and can lower the participant's immune system's sensitization to kidney donors, making it easier to find a well-matched kidney for them.

The study treatment is comprised of two drugs, Darzalex® (daratumumab) and Nulojix® (belatacept). Daratumumab is licensed for treatment of multiple myeloma and belatacept is licensed for prevention of rejection after kidney transplant. Eligible participants will receive infusions of daratumumab and belatacept over a 10-week period in Cohort 1. Eligible participants will receive infusions of daratumumab and belatacept over a 14-week period in Cohort 2. An interim safety and efficacy analysis will occur after the first 5 participants have received study treatment. All subjects will undergo HLA antibody assessments and bone marrow aspiration prior to and after completion of treatment and receive 42 weeks of follow up after completing treatment. Participants who prematurely discontinue study therapy will receive follow up through 56 weeks after their baseline visit. Subjects who receive a kidney transplant while in the study will receive standard of care immunosuppression and undergo 52 weeks of follow up. Living donors will participate for one study visit to provide blood collection.

Being tested
daratumumab, belatacept, Bone marrow aspiration
Keywords
calculated panel reactive antibodies (cPRA), desensitization therapy, human leukocyte antigen (HLA) desensitization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • daratumumabBiological

    Also called Darzalex®, immunoglobulin G1 kappa human monoclonal antibody, IgG1k human mAb

    Daratumumab is a CD38 (Cluster of Differentiation 38)-directed cytolytic monoclonal antibody indicated for the treatment of multiple myeloma. In this study, daratumumab will be used in highly sensitized subjects without myeloma who are awaiting a kidney transplant.

    Definition of highly sensitized: Potential kidney transplant recipients with either:

    • calculated panel reactive antibodies (cPRA) ≥99.9% awaiting deceased donor transplant, or
    • cPRA >98% (with >5 years of waiting time) awaiting living donor transplant

  • belataceptBiological

    Also called Nulojix®

    Belatacept, a monoclonal antibody, is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. In this study, belatacept will be used in subjects who have not received a kidney transplant.

  • Bone marrow aspirationProcedure or surgery

    Subjects will undergo a bone marrow aspiration prior to starting the study regimen and at 12 weeks after starting the study regimen. In subjects who undergo a kidney transplant during the study, another bone marrow aspiration will be done if it has been >4 weeks since the previous bone marrow aspiration.

Study groups in NCT04827979
Study groupRoleWhat they receive
Cohort 1 (N=5 Subjects)ExperimentalMultiple intravenous infusions of daratumumab and belatacept over 10 weeks: * Daratumumab will be administered intravenously at a dose of 8 mg/kg weekly for 4 weeks, then every other week for 4 weeks (week 9 and week 11). The dose administered will be calculated based on the actual body weight of the subject at each visit. * Belatacept will be administered intravenously at a dose of 10 mg/kg every 2 weeks starting at week 8 (dosed at weeks 8, 10, 12, and 14). The total infusion dose of belatacept will be based on the actual body weight of the subject at the baseline visit, and will not be modified during the course of therapy, unless there is a change in body weight of greater than 10%.
Receives: Biological: daratumumab; Biological: belatacept; Procedure: Bone marrow aspiration
Cohort 2 (N=10 Subjects)ExperimentalThe enrollment of ten additional subjects is dependent on the results in Cohort 1. Multiple intravenous infusions of daratumumab and belatacept over 14 weeks:° * Daratumumab will be administered intravenously at a dose of 8 mg/kg for the first dose, then 16 mg/kg for subsequent given weekly for 3 weeks, then every 2 weeks for 2 doses (week 9 and week 11). The dose administered will be calculated based on the actual body weight of the subject at each visit. * Belatacept will be administered intravenously at a dose of 10 mg/kg every 2 weeks starting at week 8 (dosed at weeks 8, 10, 12, 14, 16 and 18). The total infusion dose of belatacept will be based on the actual body weight of the subject at the baseline visit and will not be modified during the course of therapy, unless there is a change in body weight of greater than 10%. * Was modified based on the safety and efficacy analysis of Cohort 1.
Receives: Biological: daratumumab; Biological: belatacept; Procedure: Bone marrow aspiration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Proportion of subjects who have not met a subject stopping rule, and remain free of all of the following through 26 weeks after starting treatment or until receiving a transplant, whichever occurs earlier:

    1. Grade 3 or higher infusion reaction
    2. Grade 3 or higher infections
    3. Any malignancy

    The study site will grade the severity of adverse events experienced by the study subjects according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Published November 27, 2017).

    Measured: 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

    Proportion of subjects who meet any one of the following compared to Baseline (Visit 0):

    1. Elimination of one human leukocyte antigen (HLA) antibody at Visit 12 (16 weeks ±7 days after starting treatment);
    2. 50% or greater reduction in the mean fluorescence intensity (MFI) of at least three HLA antibodies at Visit 12 (16 weeks ±7 days after starting treatment); and/or
    3. Kidney transplant with a previously incompatible donor within 26 weeks after starting treatment without graft loss due to acute antibody mediated rejection occurring within the first four weeks post-transplant and caused by an anamnestic response.

    Measured: 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

    Proportion of subjects who meet any one of the following compared to Baseline (Visit 0):

    1. Elimination of one human leukocyte antigen (HLA) antibody at Visit 14 (26 weeks ±7 days after starting treatment);
    2. 50% or greater reduction in the mean fluorescence intensity (MFI) of at least three HLA antibodies at Visit 14 (26 weeks ±7 days after starting treatment); and/or
    3. Kidney transplant with a previously incompatible donor within 52 weeks after starting treatment without graft loss due to acute antibody mediated rejection occurring within the first four weeks post-transplant and caused by an anamnestic response.

    Measured: Baseline (Visit 0) up to 52 weeks post treatment initiation

Secondary outcomes (11)

  1. Proportion of subjects transplanted with a previously incompatible donor within 52 weeks after starting treatment - Cohort 1

    Proportion of subjects transplanted with a donor, to whom Donor Specific Antibodies (DSA) was previously positive and had reduced by >/= 50% reduction at the time of transplant, within 52 weeks after starting treatment

    Subjects may receive a kidney transplant while in the study, either from a living or deceased donor to whom they were previously compatible, or from a previously incompatible donor in case there is a significant reduction in HLA antibody.

    Measured: Within 52 weeks post treatment initiation

  2. Proportion of subjects with biopsy-proven acute or chronic antibody mediated rejection (AMR) (based on the assessment of central pathologist) within 52 weeks post-transplant in subjects who undergo a kidney transplant

    Antibody mediated rejection (AMR) is an important cause of graft loss after organ transplantation and is caused by anti-donor-specific antibodies, especially anti- human leukocyte antigen (HLA) antibodies.

    Measured: Within 52 weeks post-transplant

  3. Number of biopsy-proven acute or chronic AMR (based on the assessment of central pathologist) events within 52 weeks post-transplant in subjects who undergo a kidney transplant

    Antibody mediated rejection (AMR) is an important cause of graft loss after organ transplantation and is caused by anti-donor-specific antibodies, especially anti- human leukocyte antigen (HLA) antibodies.

    Measured: Within 52 weeks post-transplant

  4. Incidence of invasive fungal infections, mycobacterial infections or Pneumocystis jirovecii infection within 16 weeks after starting treatment

    A measure of infection-related morbidity.

    Measured: Within 16 weeks post treatment initiation

  5. Incidence of invasive fungal infections, mycobacterial infections or Pneumocystis jirovecii infection within 26 weeks after starting treatment

    A measure of infection-related morbidity.

    Measured: Within 26 weeks post treatment initiation

  6. Incidence of invasive fungal infections, mycobacterial infections or Pneumocystis jirovecii infection within 52 weeks after starting treatment

    A measure of infection-related morbidity.

    Measured: Within 52 weeks post treatment initiation

  7. Incidence of cytomegalovirus (CMV) disease within 16 weeks after starting treatment

    CMV disease defined by the presence of detectable CMV in the blood and the presence of other clinical manifestations attributable to the CMV virus.

    Measured: Within 16 weeks post treatment initiation

  8. Incidence of cytomegalovirus (CMV) disease within 26 weeks after starting treatment

    CMV disease defined by the presence of detectable CMV in the blood and the presence of other clinical manifestations attributable to the CMV virus.

    Measured: Within 26 weeks post treatment initiation

  9. Incidence of cytomegalovirus (CMV) disease within 52 weeks after starting treatment

    CMV disease defined by the presence of detectable CMV in the blood and the presence of other clinical manifestations attributable to the CMV virus.

    Measured: Within 52 weeks post treatment initiation

  10. Incidence of cytomegalovirus (CMV) infection within 52 weeks after starting treatment

    CMV infection confirmed by the presence of detectable CMV in blood by polymerase chain reaction [PCR] diagnostic testing, regardless of whether signs or symptoms are present.

    Measured: Within 52 weeks post treatment initiation

  11. Incidence of post-transplant lymphoproliferative disorder (PTLD)

    As per diagnosis by local pathologist and treating physician.

    Measured: Within 52 weeks post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start1 Nov 2021
  3. Primary completion2 Apr 2026
  4. Study completion10 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04827979
Sponsor's protocol ID
DAIT ITN090ST
Other IDs
UM1AI109565, NIAID CRMS ID#: 38686
Acronym
ATTAIN
Status last verified
Oct 2026
First submitted
30 Mar 2021
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

Publications

  • Mayer KA, Budde K, Diebold M, Halloran PF, Bohmig GA. Targeting CD38 in Antibody-Mediated Rejection. Transpl Int. 2025 May 15;38:14343. doi: 10.3389/ti.2025.14343. eCollection 2025.

    PubMed 40444214

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing daratumumab, belatacept and Bone marrow aspiration in people with Highly Sensitized Prospective Kidney Transplant Recipients, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline up to 26 weeks post treatment initiation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04827979, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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