Belatacept in Heart Transplantation
Public ClinicalTrials.gov record NCT06478017. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Belatacept With Delayed Tacrolimus Withdrawal Versus Standard-of-Care Tacrolimus in Heart Transplant Recipients (RTB-013)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06478017
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 66 participants
Conditions and interventions
Conditions
Interventions
- Belatacept Drug
- Tacrolimus Drug
- Mycophenolate Mofetil/Sodium Drug
- Prednisone Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 76 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 29, 2025 (Actual)
- Primary completion
- Jan 31, 2028 (Estimated)
- Completion
- Jan 31, 2028 (Estimated)
- Last update posted
- Oct 9, 2026
2025 – 2028
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars Sinai Heart Institute/ Cedars Sinai Medical (Site # 71146) | Los Angeles | California | 90048 | Recruiting |
| Tampa General Hospital (Site # 71150) | Tampa | Florida | 33606 | Recruiting |
| Emory University Hospital (Site #: 71103) | Atlanta | Georgia | 30322 | Recruiting |
| St. Luke's Hospital of Kansas City (Site #: 71173) | Kansas City | Missouri | 64111 | Recruiting |
| NYU Langone Health (Site # 71177) | New York | New York | 10016 | Recruiting |
| Mount Sinai Ichan School of Medicine (Site #: 71115) | New York | New York | 10025 | Not yet recruiting |
| Medical University South Carolina (Site #: 71140) | Charleston | South Carolina | 29425 | Not yet recruiting |
| University of Utah Medical Center (Site # 71126) | Salt Lake City | Utah | 84132 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06478017, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 9, 2026 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06478017 live on ClinicalTrials.gov.