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Heart TransplantPhase 2NCT06478017

Belatacept in Heart Transplantation

A Phase 2 study testing Belatacept, Tacrolimus and Mycophenolate Mofetil/Sodium in people with Heart Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 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

This is a phase 2, prospective, multi-center, open-label clinical trial. Sixty-six (66) primary heart transplant recipients will be randomized (1:2) to receive either standard-of-care, tacrolimus-based immunosuppression, or a belatacept-based regimen with gradual tacrolimus withdrawal over 9-months post-transplant. Read more about this study

Who is it for?
Ages 18 to 76 years
Conditions the study is for
Heart Transplant
What is being tested?
Belatacept, Tacrolimus and Mycophenolate Mofetil/Sodium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
8 sitesUnited States
Study dates
29 Jan 2025to 31 Jan 2028
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 76 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Study entry
  • Subject must be able to understand the purpose of the study and be willing to participate and provide written consent
  • Recipient of a primary heart transplant (heart transplant only)
  • Epstein-Barr Virus (EBV) seropositive (VCA IgG, EBNA IgG). If EBNA is not available, enrollment may proceed but the result must be available prior to randomization.
  • Agreement to use contraception; according to the Food and Drug Administration (FDA) Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective. Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used for the duration of the study
  • In the absence of a contraindication, vaccinations must be up to date per the Division of Allergy, Immunology, and Transplantation (DAIT) Vaccination Guidance for Patients in Transplant Trials (niaidtransplantstudies.org)
Show all 14Show fewer
  • Mechanical support or investigational drug trials where the intervention ends at the time of transplantation are permitted.
  • Randomization
  • Recipient of a primary heart transplant
  • No desensitization therapy prior to transplant
  • Negative crossmatch actual or virtual, on the most recent sera as determined by the participating study center
  • Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) prior to randomization
  • Agreement to use contraception; according to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective. Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used for the duration of the study. Those who choose oral contraception must agree to use a second form of contraception after administration of study drug for a period of 1 year after the last dose of study drug
  • Pre-transplant eGFR (CKD-epi) >30ml/min/1.73m^2.

Who cannot join

  • Study entry
  • Candidate for multiple solid organ or tissue transplants
  • Prior history of any organ, tissue, or cellular transplant
  • Currently breast-feeding a child or plans to become pregnant during the timeframe of the study follow up period
  • History of severe allergic and/or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Known hypersensitivity to NULOIX (belatacept) or ORENCIA (Abatacept)
Show all 66Show fewer
  • Previous treatment with NULOIX (belatacept) or ORENCIA (Abatacept)
  • Epstein Barr Virus (EBV) seronegative or indeterminant
  • Human Immunodeficiency Virus (HIV) positive
  • Hepatitis B surface antigen positive
  • Hepatitis B core antibody positive
  • Hepatitis C virus antibody (HCV Ab+) and hepatitis C virus (HCV) Polymerase Chain Reaction (PCR) positive patients
  • Patients with active Tuberculosis (TB) in the past 2 years, whether or not it was adequately treated; patients with documented treatment of active TB greater than 2 years ago will be allowed to participate if there is documentation of adequate treatment according to locally accepted clinical practice
  • Subjects must be tested for latent TB infection (LTBI) within a year prior to transplant. Testing should be conducted using either a PPD or Interferon-gamma release assay (i.e., QuantiFERON-TB, T-SPOT.TB). Patients with a positive test for latent TB infection (LTBI) must have completed appropriate therapy for LTBI (https://www.cdc.gov/tb/topic/treatment/ltbi.htm). A subject is considered eligible only if they have a negative test for LTBI within one year prior to transplant OR if they have completed appropriate LTBI therapy within one year prior to transplant
  • Positive serology for T. cruzi or known/suspected history of Chagas disease
  • Participants currently or formerly residing in regions of the US that are highly endemic for coccidiomycosis will undergo serological testing, as per the site's standard of care. Participants with positive serology who have previously been fully treated, will be permitted to participate pending full treatment, and then require prophylaxis as further outlined in Section 7 for the duration of the study. Participants with negative serology who reside in regions where coccidiomycosis is endemic are eligible for enrollment only if they receive prophylaxis for the duration of the study. Endemic regions are determined by site based on local standard of care
  • Findings on pre-transplant or pre-randomization chest x-ray or CT scan suggestive of fungal infection where an alternative etiology is not identified. Participants with a history of positive serologies for histoplasmosis or blastomycosis, performed for clinical indications will be permitted to participate if they have a normal chest x-ray or CT scan but require prophylaxis
  • Known active current viral, fungal, mycobacterial or other infections (including, but not limited to atypical mycobacterial disease and herpes zoster), not including drive line infections
  • Current white blood cell (WBC) count <3.0 or an absolute neutrophil count (ANC) of less than 1500 cells/mm^3 or recurrent leukopenia that is likely to necessitate immunosuppression reduction after transplant, as determined by the site PI
  • History of active inflammatory bowel disease, chronic diarrhea, or malabsorption
  • History of malignancy, per discretion of oncology consult and study oversight team, will be permitted to participate
  • History of AL amyloidosis
  • Patients who are administered or intended to be administered induction therapy (cytolytic agents such as anti-thymocyte globulin or anti-IL2R therapies such as basiliximab) in the immediate peri-transplant period
  • Patients who i) have undergone desensitization, ii) are undergoing or are planned to undergo desensitization, or iii) are intended to receive therapeutic interventions that are used for the purpose of desensitization prior to transplant;
  • The use of immunosuppressive biologics within 1 month prior to transplant is not permitted. Non-immunosuppressive biologics such as proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors must be stopped at the time of transplant
  • Patients for whom there is an intent to administer biologics other than those indicated by protocol during the study period
  • The intended use of high dose (>= 2g/kg) intravenous immunoglobulin before or at the time of transplant or before study drug administration
  • A personal history of severe hypogammaglobulinemia (<300mg/dL)
  • Intent to give the patient a live vaccine within 30 days prior to randomization
  • Use or intended use of other investigational drugs after transplant
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the potential participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
  • Randomization
  • Recipient of multiple solid organ or tissue transplants
  • Prior history of any organ, tissue, or cellular transplant
  • Currently breast-feeding a child or plans to become pregnant during the timeframe of the study follow up period
  • History of severe allergic anaphylactic reactions to humanized or murine monoclonal antibodies
  • Known hypersensitivity to Belatacept (NULOJIX) or Abatacept (ORENCIA)
  • Previous treatment with Belatacept (NULOJIX) or Abatacept (ORENCIA)
  • Epstein Barr Virus (EBV) seronegative or indeterminant (recipient must be seropositive for VCA IgG and EBNA IgG)
  • HIV positive patient
  • Hepatitis B surface antigen positive patient
  • Hepatitis B core antibody positive patient
  • Hepatitis B negative transplant recipient that received a transplant from a Hepatitis B core antibody positive donor
  • Hepatitis C virus antibody (HCV Ab+) and HCV PCR positive patients
  • Recipient of allograft from a hepatitis C virus nucleic acid test (NAT) positive donor
  • Patients with a previous history of active Tuberculosis (TB) in the past 2 years, whether or not it was adequately treated; patients with documented treatment of active TB greater than 2 years ago will be allowed to participate if there is documentation of adequate treatment according to locally accepted clinical practice
  • Subjects must be tested for latent TB infection (LTBI) within a year prior to transplant. Testing should be conducted using either a PPD or Interferon-gamma release assay (i.e., QuantiFERON-TB, T-SPOT.TB). Patients with a positive test for latent TB infection (LTBI) must complete appropriate therapy for LTBI (https://www.cdc.gov/tb/topic/treatment/ltbi.htm). A subject is considered eligible only if they have a negative test for LTBI within one year prior to transplant OR if they have completed appropriate LTBI therapy within one year prior to transplant
  • Positive serology for T. cruzi or known/suspected history of Chagas disease
  • Participants currently or formerly residing in regions of the US that are highly endemic for coccidiomycosis will undergo serological testing, as per the site's standard of care. Participants with positive serology who have previously been fully treated, will be permitted to participate but require prophylaxis as further outlined in Section 7 of the protocol for the duration of the study. Participants with negative serology who reside in regions where coccidiomycosis is endemic are eligible for enrollment only if they receive prophylaxis for the duration of the study. Endemic regions are determined by site based on local standard of care
  • Findings on pre-transplant or pre-randomization chest x-ray or CT scan suggestive of fungal infection where an alternative etiology is not identified. Participants with a history of positive serologies for histoplasmosis or blastomycosis, performed for clinical indications, will be permitted to participate if they have a normal chest x-ray or CT scan but require prophylaxis as further outlined in Section 7 of the protocol
  • Known active current viral, fungal, mycobacterial or other infections (including, but not limited to atypical mycobacterial disease and herpes zoster), not including drive line infections
  • Current white blood cell (WBC) count <3.0 or an absolute neutrophil count (ANC) of less than 1500 cells/mm^3 or recurrent leukopenia that is likely to necessitate immunosuppression reduction after transplant, as determined by the site PI
  • CMV high risk mismatch (D+/R-); if donor is CMV seropositive, recipient serology must be based on a sample obtained prior to start of the transplant operation
  • History of active inflammatory bowel disease, chronic diarrhea, or malabsorption
  • History of malignancy, per discretion of oncology consult and study oversight team, will be permitted to participate
  • History of AL amyloidosis
  • Patients who are administered or intended to be administered induction therapy (cytolytic agents such as anti-thymocyte globulin or anti-IL2R therapies such as basiliximab) in the immediate peri-transplant period
  • Patients who have undergone desensitization or received therapeutic interventions that are used for the purpose of desensitization prior to transplant
  • No donor specific antibodies before or at the time of transplant as determined by local site practices
  • Patients who have been treated with immunosuppressive biologics within 1 month prior to transplant (non-immunosuppressive biologics must have been stopped at the time of transplant)
  • Patients for whom there is an intent to administer biologics other than those indicated by protocol during the study period
  • Patients who are administered or intended to be administered high dose (>=2g/kg) intravenous immunoglobulin in the immediate post-transplant period
  • A personal history of severe hypogammaglobulinemia (<300mg/dL)
  • Receipt of a live vaccine within 30 days prior to randomization
  • Intent to use any other investigational drugs after transplantation
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study

Trial locations and contacts

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

Yvonne Morrison contact

301-706-9137

ymorrison@niaid.nih.gov

Jaclyn Evans contact

240-669-5470

Jaclyn.evans@nih.gov

8 sites in 1 country

United States8 sites, 8 recruiting

  • Emory University Hospital (Site #: 71103)

    Atlanta, Georgia, 30322

    Eve Elizabeth Pennie, 404-712-1342, eve.elizabeth.pennie@emory.edu

    Recruiting

  • Medical University South Carolina (Site #: 71140)

    Charleston, South Carolina, 29425

    Shaquanda Goodwine, 843-876-5783, amitrano@musc.edu

    Not yet recruiting

  • St. Luke's Hospital of Kansas City (Site #: 71173)

    Kansas City, Missouri, 64111

    Marissa Beidelschies, 816-932-5634, mbeidelchies@saint-lukes.org

    Recruiting

  • Cedars Sinai Heart Institute/ Cedars Sinai Medical (Site # 71146)

    Los Angeles, California, 90048

    Jeremy Duenas, (310) 248-7193, jeremy.duenas@csmns.org

    Recruiting

  • NYU Langone Health (Site # 71177)

    New York, New York, 10016

    Andrea Kim, 646-457-0987, Andrea.Kim@nyulangone.org

    Recruiting

  • Mount Sinai Ichan School of Medicine (Site #: 71115)

    New York, New York, 10025

    Katharine Idrissi, 646-531-1170, Katharine.idrissi2@mountsinai.org

    Not yet recruiting

  • University of Utah Medical Center (Site # 71126)

    Salt Lake City, Utah, 84132

    Jeff Gibbs, MBBS, 801-585-2944, Jeffrey.gibbs@hsc.utah.edu

    Recruiting

  • Tampa General Hospital (Site # 71150)

    Tampa, Florida, 33606

    Alecia Sorrells, 813-844-8754, asorrells@tgh.org

    Recruiting

Other trials in United States

About this study

Official title: Belatacept With Delayed Tacrolimus Withdrawal Versus Standard-of-Care Tacrolimus in Heart Transplant Recipients (RTB-013)

This is a phase 2, prospective, multi-center, open-label clinical trial. Sixty-six (66) primary heart transplant recipients will be randomized (1:2) to receive either standard-of-care, tacrolimus-based immunosuppression, or a belatacept-based regimen with gradual tacrolimus withdrawal over 9-months post-transplant. Both study arms will receive CellCept® (mycophenolate mofetil- MMF) or Myfortic® (mycophenolate sodium). Corticosteroids will be continued throughout the study in the belatacept arm.

The primary objective is to evaluate whether NULOJIX® (belatacept), when implemented with gradual tacrolimus withdrawal over 9 months, is safe with respect to preventing the composite endpoint of acute cellular rejection (ACR) >= International Society of Heart and Lung Transplantation (ISHLT) 2R, hemodynamic compromise rejection in the absence of a biopsy or histological rejection, re-transplantation, and death at 18 months post-transplant.

Being tested
Belatacept, Tacrolimus, Mycophenolate Mofetil/Sodium, Prednisone
Keywords
Heart transplant, Transplantation, Standard of care, Belatacept, Tacrolimus

What participants receive

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

  • BelataceptDrug

    Also called NULOJIX

    Patients will receive 10mg/kg on Day 3 post-transplant (72 hours +/- 12 hours post-transplant)

    Day 7 post-transplant (+/- 6 hours)

    Day 16 (End of Week 2 after 1st dose of belatacept) post-transplant (+/- 2 days)

    Day 30 (End of Week 4 after 1st dose of belatacept) post-transplant (+/- 3 days)

    Day 58 (Week 8) post-transplant (+/- 3 days)

    Day 86 (Week 12) post-transplant (+/- 3 days)

    Patients will receive 5mg/kg Every 28 days (+/- 3 days) thereafter

  • TacrolimusDrug

    Also called Prograf

    Prograf (tacrolimus) or tacrolimus generic

  • Mycophenolate Mofetil/SodiumDrug

    Also called CellCept, Myfortic

    CellCept (mycophenolate mofetil- MMF), or Myfortic (mycophenolate sodium)

  • PrednisoneDrug

    Prednisone

Study groups in NCT06478017
Study groupRoleWhat they receive
Belatacept + Tacrolimus withdrawalExperimental1. Maintenance Immunosuppression: NULOJIX (belatacept) 2. Maintenance Immunosuppression: CellCept (mycophenolate mofetil- MMF), or Myfortic (mycophenolate sodium) 3. Calcineurin Inhibitors (CNI) Taper: Prograf® (tacrolimus), or tacrolimus generic 4. Corticosteroid: Prednisone (no less than 5mg per day continued throughout the study period)
Receives: Drug: Belatacept; Drug: Tacrolimus; Drug: Mycophenolate Mofetil/Sodium; Drug: Prednisone
Standard-of-CareActive comparator1. Maintenance Immunosuppression: Prograf (tacrolimus), or tacrolimus generic; 2. Maintenance Immunosuppression: CellCept (mycophenolate mofetil- MMF), or Myfortic (mycophenolate sodium); 3. Corticosteroid +/- taper: Prednisone
Receives: Drug: Tacrolimus; Drug: Mycophenolate Mofetil/Sodium; Drug: Prednisone

What is being measured

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

  1. Proportion of subjects who experience acute cellular rejection (ACR) >ISHLT 2R (local or core read), hemodynamic compromise (HDC) rejection in the absence of a biopsy or histological rejection, re-transplantation, or death as a composite endpoint.

    Measured: From randomization to 18 months post-transplantation

Secondary outcomes (23)

  1. Slope of estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation

    Measured: From baseline to 18 months post-transplantation, assessed at Baseline, Randomization, Month 1, 6 and 18

  2. Proportion of subjects with eGFR <60mL/min/1.73m^2 measured by CKD-EPI

    Measured: From randomization to 18 months post-transplantation

  3. Proportion of subjects with eGFR<45mL/min/1.73m^2 measured by CKD-EPI

    Measured: From randomization to 18 months post-transplantation

  4. Mean change in albumin/creatinine ratio in urine

    Measured: From baseline to 18 months post-transplantation

  5. Change in Chronic Kidney Disease (CKD) stage measured using the mean difference on a continuous measurement scale

    Chronic Kidney Disease scale:

    Stage 1: Glomerular Filtration Rate (GFR) >90mL/min Stage 2: GFR = 60-89mL/min Stage 3A: GFR=45-59mL/min Stage 3B: GFR=30-44mL/min Stage 4: GFR=15-29mL/min Stage 5: GFR<15mL/min

    Measured: From Baseline to 18 months post-transplantation, assessed at Baseline, Month 1, 12 and 18

  6. Proportion of subjects with CKD stage 4 or 5

    Measured: From randomization to 18 months, assessed at Month 12 and 18

  7. Mean difference in eGFR between the two arms

    Measured: 12 months and 18 months

  8. Proportion of subjects who are free from any detection of de novo donor-specific antibodies (dnDSA)

    Measured: From randomization to 18 months post-transplantation

  9. Number of de novo donor specific antibodies per patient

    Measured: From randomization to 18 months post-transplantation

  10. Proportion of subjects who are free from ACR greater than or equal to 2R

    Measured: From randomization to 18 months post-transplantation

  11. Proportion of subjects who are free from ACR 3R

    Measured: From randomization to 18 months post-transplantation

  12. Proportion of subjects who are free from any treated rejection

    Measured: From randomization to 18 months post-transplantation

  13. Proportion of subjects who are free from antibody mediated rejection (AMR) (AMR > ISHLT AMR 1)

    Measured: From randomization to 18 months post-transplantation

  14. Proportion of subjects who are free from hemodynamic compromise rejection in the absence of a biopsy or histological rejection

    Measured: From randomization to 18 months post-transplantation

  15. Proportion of subjects who are free from mixed rejection (ACR > ISHLT 2R ACR and AMR > ISHLT AMR 1)

    Measured: From randomization to 18 months post-transplantation

  16. Incidence of acute cellular rejection (ACR) >= International Society of Heart and Lung Transplantation (ISHLT) 2R

    Measured: From randomization to 18 months post-transplantation

  17. Incidence of acute cellular rejection (ACR) >= International Society of Heart and Lung Transplantation (ISHLT) 3R

    Measured: From randomization to 18 months post-transplantation

  18. Cumulative incidence of serious infections, including CMV viremia and disease, requiring inpatient/intravenous therapy

    Measured: From randomization to 18 months post-transplantation

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

    Measured: From randomization to 18 months post-transplantation

  20. Incidence of death

    Measured: From randomization to 18 months post-transplantation

  21. Incidence of re-listing or re-transplantation

    Measured: From randomization to 18 months post-transplantation

  22. Incidence of malignancies

    Measured: From randomization to 18 months post-transplantation

  23. Incidence of interruption/discontinuation of study drug

    Measured: From randomization to 18 months post-transplantation

Timeline

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

  1. First posted27 Jun 2024
  2. Study start29 Jan 2025
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Jan 2028 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06478017
Sponsor's protocol ID
DAIT RTB-013
Status last verified
Sep 2026
First submitted
7 Jun 2024
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Belatacept, Tacrolimus and Mycophenolate Mofetil/Sodium in people with Heart Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 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 14 inclusion and 66 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 9 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 8 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 Yvonne Morrison (301-706-9137, ymorrison@niaid.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects who experience acute cellular rejection (ACR) >ISHLT 2R (local or core read), hemodynamic compromise (HDC) rejection in the absence of a biopsy or histological rejection, re-transplantation, or death as a composite endpoint. (time frame: From randomization to 18 months post-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 NCT06478017.

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 9 Oct 2026; AzTrials last refreshed its copy on 3 Nov 2026.

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