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RECRUITING Phase 2

Belatacept in Heart Transplantation

NCT06478017 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG Prednisone
  • DRUG Tacrolimus
  • DRUG Belatacept
  • DRUG Mycophenolate Mofetil/Sodium

Study Locations (4)

California

  • Cedars Sinai Heart Institute/ Cedars Sinai Medical (Site # 71146) — Los Angeles

Florida

  • Tampa General Hospital (Site # 71150) — Tampa

New York

  • NYU Langone Health (Site # 71177) — New York

Utah

  • University of Utah Medical Center (Site # 71126) — Salt Lake City

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2025-01-29
Est. Completion 2028-01-31
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06478017

The ClinicalTrials.gov registry entry for NCT06478017 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Heart Transplant appearing as the primary indexed condition, and to 4 interventions — of which Prednisone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06478017 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06478017 about?

NCT06478017 is a clinical study titled "Belatacept in Heart Transplantation". 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 ...

What is the current status of trial NCT06478017?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2025-01-29. Estimated completion is 2028-01-31.

What conditions does trial NCT06478017 study?

This clinical trial studies the following conditions: Heart Transplant. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06478017?

The interventions under investigation include: Prednisone (DRUG), Tacrolimus (DRUG), Belatacept (DRUG), Mycophenolate Mofetil/Sodium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06478017?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06478017 being conducted?

This trial has 4 study locations across California, Florida, New York, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial