Health TrialsbyHealthPanel

Belatacept in De Novo Heart Transplantation

ConditionHeart Transplantation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNYU Langone Health

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Belatacept

    Drug

    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.

  • Tacrolimus

    Drug

    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 Mofetil

    Drug

    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).

  • Corticosteroid

    Drug

    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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: BelataceptExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

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.

Time frame
Up to 18 months after transplantation

Secondary outcomes

1

Change in Estimated Glomerular Filtration Rate (eGFR)

Time frame
Baseline and 18 months
2

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

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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