Health TrialsbyHealthPanel

Belatacept in Heart Transplantation

ConditionHeart Transplant
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-76
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Belatacept

    Drug

    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

  • Tacrolimus

    Drug

    Prograf (tacrolimus) or tacrolimus generic

  • Mycophenolate Mofetil/Sodium

    Drug

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

  • Prednisone

    Drug

    Prednisone

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Belatacept + Tacrolimus withdrawalExperimental treatment 4 interventions
Group B: Standard-of-CareActive comparator 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame
From randomization to 18 months post-transplantation

Secondary outcomes

1

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

Time frame
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

Time frame
From randomization to 18 months post-transplantation
3

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

Time frame
From randomization to 18 months post-transplantation
4

Mean change in albumin/creatinine ratio in urine

Time frame
From baseline to 18 months post-transplantation

Other outcomes

Sponsors and contacts

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

National Institute of Allergy and Infectious Diseases (NIAID)

Lead sponsor

Source ClinicalTrials.gov
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