Belatacept in Heart Transplantation

Conditions

• Heart Transplant

Eligibility Criteria

Sex

ALL

Age

18 Years - 71 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Jan 29, 2025

Status verified

Apr 2026

Primary completion

Jan 31, 2028

Completion

Jan 31, 2028

Study Design

Enrollment

66 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Belatacept + Tacrolimus withdrawal
  1. 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)
• Active Comparator: Standard-of-Care
  1. Maintenance Immunosuppression: Prograf (tacrolimus), or tacrolimus generic; 2. Maintenance Immunosuppression: CellCept (mycophenolate mofetil- MMF), or Myfortic (mycophenolate sodium); 3. Corticosteroid +/- taper: Prednisone

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 ]

Central Contacts

• Yvonne Morrison
  301-706-9137
  [email protected]
• Jaclyn Evans
  240-669-5470
  [email protected]

Locations (5)

Find similar trials in Los Angeles, CA

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