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

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. 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

Age range

18–71 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Belatacept

  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

• Drug
  Tacrolimus

  Prograf (tacrolimus) or tacrolimus generic

• Drug
  Mycophenolate Mofetil/Sodium

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

• Drug
  Prednisone

  Prednisone

Locations (5)