AzTrials
AzTrials

Heart TransplantationPhase 2NCT04477629

Belatacept in De Novo Heart Transplantation

A Phase 2 study testing Belatacept, Tacrolimus and Mycophenolate Mofetil in people with Heart Transplantation, run by NYU Langone Health at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to determine if Belatacept is safe to give to adult heart transplant recipients. Belatacept (NULOJIX) is an anti-rejection medication that is available through a prescription from a doctor. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Heart Transplantation
What is being tested?
Belatacept, Tacrolimus and Mycophenolate Mofetil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
6 Aug 2020to Sep 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or non-pregnant female, age ≥18 to ≤75 years
  • Awaiting a primary heart transplant (listed for heart transplant only)
  • Epstein-Barr virus (EBV) IgG seropositive
  • Able to take oral medication and willing to adhere to the belatacept infusion regimen
  • No desensitization therapy prior to transplant
  • Vaccinations should be up to date for hepatitis B, influenza pneumococcal, haemophilus, varicella zoster virus (VZV), measles, mumps and rubella (MMR), and Human Papilloma Virus (HPV) (for participants < 45 years of age) when available
Show all 9Show fewer
  • Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) prior to randomization
  • Mechanical support or investigational drug trials where the intervention ends at the time of transplantation are permitted
  • Negative virtual crossmatch

Who cannot join

  • Candidates awaiting multiorgan transplant
  • Estimated glomerular filtration rate (eGFR) < 45 ml/min/m2
  • Candidates with prior organ transplant
  • Candidates actively being treated with immunosuppressive therapies
  • Candidates who have a history of treatment with cytolytic therapy (e.g. anti-thymocyte globulin)
  • Candidates who are intended to be treated with cytolytic therapy in the post-transplant period as induction therapy
Show all 28Show fewer
  • EBV (IgG) seronegative
  • Active or prior infection with human immunodeficiency virus (HIV), Hepatitis C (HCV), Hepatitis B (HBV)
  • Untreated latent tuberculosis (TB)
  • All potential candidates will be screened prior to enrolment for a history of tuberculosis (chest radiograph and tuberculosis-Interferon Gamma Release Assay (TB-IGRA) or tuberculin skin tests (TST)). Potential candidates with latent TB must be treated prior to study enrolment
  • Prior history of active tuberculosis
  • Prior history of central nervous system infection
  • Known active current viral, fungal, mycobacterial, or other infections excluding driveline infections - potential participants from endemic areas will additionally be screened for histoplasmosis, blastomycosis, coccidioidomycosis, and strongyloidiasis
  • Vaccination with a live vaccine within the past 30 days
  • Malignancy within the last 5 years
  • Any previous treatment with alkylating agents or total lymphoid irradiation
  • Sensitized heart transplant candidates with panel-reactive antibodies (PRA) >50% or those receiving desensitization treatment
  • Prior treatment with belatacept or abatacept
  • History of severe allergic anaphylactic reactions to humanized or murine monoclonal antibodies
  • Treatment with a disease modifying anti-rheumatic drug (DMARD) or other biologic agent (monoclonal antibody) within the past year
  • Treatment with another investigational drug or other intervention at the time of transplant (excluding device or intervention mechanical support or investigational drug trials where the intervention ends at the time of transplant)
  • Potential candidates for whom a calcineurin inhibitor other than tacrolimus (Prograf®) is anticipated after transplant. If during the course of the study, a participant is transitioned to another calcineurin inhibitor due to side effects or inability to achieve stable therapeutic trough levels, they may continue in the study at the discretion of the investigator
  • Any potential participant who remains on mechanical circulatory support for > 72 hours post-transplant will be excluded from the study
  • The need for ongoing high dose vasopressor support > 72 hours post-transplant
  • The need or anticipated need for post-transplant dialysis
  • Platelet count <75,000/mm (within 24 hours prior to transplant)
  • Absolute neutrophil count (ANC) of less than 2000/mm3 within 24 hours prior to transplant
  • Any past or current medical problems or findings on history, physical examination, or laboratory testing, not listed above, that in the opinion of the investigator, may pose additional risk to participation, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of study results

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Andrea Kim contact

646-457-0987

Andrea.Kim@nyulangone.org

Dylan McDonald contact

Dylan.Mcdonald@nyulangone.org

United States2 sites, 1 recruiting

  • NYU Langone Health

    New York, New York, 10016

    Andrea Kim, Andrea.Kim@nyulangone.org

    Marlena Habal, MD

    Recruiting

  • Columbia University

    New York, New York, 10032

    Active, not recruiting

Other trials in United States

About this study

Official title: Belatacept in De Novo Heart Transplantation - Pilot Study

The purpose of this study is to determine if Belatacept is safe to give to adult heart transplant recipients. Belatacept (NULOJIX) is an anti-rejection medication that is available through a prescription from a doctor. In this research study, belatacept is being used in an investigational manner (not for the purpose that it is approved for).

Read the detailed description

Long-term outcomes after heart transplant remain suboptimal with renal failure and cardiac allograft vasculopathy contributing to morbidity and mortality. Belatacept is Food and Drug Administration (FDA) approved for use in kidney transplant recipients on the basis of two randomized controlled trials, which demonstrated important renal sparing benefits, a reduction in de novo donor-specific antibodies (DSA), and improved long-term outcomes. In this study, ten (10) primary heart transplant recipients will receive belatacept in addition to mycophenolate mofetil, corticosteroids, and a tacrolimus tapering regimen.

Being tested
Belatacept, Tacrolimus, Mycophenolate Mofetil, Corticosteroid
Keywords
Heart Transplant, Nulojix

What participants receive

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

  • BelataceptDrug

    Also called Nulojix

    Belatacept will be given in the following way - 10mg/kg IV day 1, 5, end of weeks 2, 4, 8, 12 then 5mg/kg every 4 weeks.

  • TacrolimusDrug

    Also called Tacrolimus taper

    Non-experimental: Tacrolimus will be given in the following way - trough level at month 1, 10-12ng/mL; month 2-3, 6-10ng/mL; month 4-6, 4-6ng/mL; months 7-9 taper off.

  • Mycophenolate MofetilDrug

    Also called MMF

    Non-experimental: MMF is part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice at 500-1500mg twice a day (BID) (dosed to tolerance and effect).

  • CorticosteroidDrug

    Also called CS

    Non-experimental: CS is part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice at a dose no less than 5mg/d.

Study groups in NCT04477629
Study groupRoleWhat they receive
BelataceptExperimentalParticipants will receive Belatacept along with an upfront tacrolimus taper Participants will also receive mycophenolate mofetil and corticosteroids are part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice.
Receives: Drug: Belatacept; Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Drug: Corticosteroid

What is being measured

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

  1. Number of Major Graft-Related Adverse Events

    Adverse events that will be counted in the total number include: Episodes of acute cellular rejection ≥ 2R/3A, antibody mediated rejection (AMR) ≥ International Society of Heart and Lung Transplantation (ISHLT) AMR 1, hemodynamically compromised rejection, development of cardiac allograft vasculopathy, graft failure occurring ≥ 14 days post-transplant, the need for re-transplant, serious infection requiring inpatient intravenous therapies, post-transplant lymphoproliferative disorder (PTLD), or death.

    Measured: Up to 18 months after transplantation

Secondary outcomes (2)

  1. Change in Estimated Glomerular Filtration Rate (eGFR)

    Measured: Baseline and 18 months

  2. Percentage of Individuals with Development of De Novo Donor Specific Antibodies (DSA)

    Measured: 18 months

Timeline

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

  1. First posted20 Jul 2020
  2. Study start6 Aug 2020
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Study population includes first-time Epstein-Barr virus (EBV) seropositive, male and non-pregnant female heart transplant recipients 18 years of age or older, who are able to provide written informed consent for the study.
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04477629
Sponsor's protocol ID
22-01135
Status last verified
Dec 2025
First submitted
16 Jul 2020
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Belatacept, Tacrolimus and Mycophenolate Mofetil in people with Heart Transplantation, run by NYU Langone Health at 2 sites 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 9 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 phase mean?

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Andrea Kim (646-457-0987, Andrea.Kim@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Major Graft-Related Adverse Events (time frame: Up to 18 months after transplantation). 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 NCT04477629.

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 4 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in