Belatacept With Delayed Tacrolimus Withdrawal Versus Standard-of-Care Tacrolimus in Heart Transplant Recipients

What is the Purpose of this Study?

This study focuses on people who are on the waitlist to receive a heart transplant. Organ transplant recipients must take medications to suppress their immune system to prevent rejection of the transplanted organ (known as immunosuppressive medications). The purpose of this study is to determine whether a medication called belatacept (Nulojix) with gradual tacrolimus (another immunosuppressant medication) withdrawal over 9 months post-transplant is safe and effective compared to standard immunosuppressive medications in heart transplant recipients. Specifically, researchers will evaluate whether taking belatacept can prevent rejection, improve kidney function, and reduce the development of unwanted antibodies to the transplanted organ called donor-specific antibodies (DSA), collectively improving outcomes after heart transplantation. Belatacept is a medication that is approved by the U.S. Food and Drug Administration (FDA) for use in adults to prevent rejection in kidney transplant recipients. The use of belatacept in heart transplant recipients is considered investigational.


Eligibility

  • Study entry
  • 1. Subject must be able to understand the purpose of the study and be willing to participate and provide written consent
  • 2. Recipient of a primary heart transplant (heart transplant only)
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Belatacept with delayed tacrolimus withdrawal versus standard-of-care tacrolimus in heart transplant recipients

Study Details
Disease Type/Condition

Other

Principal Investigator

Kobashigawa, Jon

Age Group

Adult

Phase

II

IRB Number

STUDY00003681

ClinicalTrials.gov ID

NCT06478017

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Kobashigawa, Jon

Age Group

Adult

Phase

II

IRB Number

RTB-013

ClinicalTrials.gov ID

NCT06478017

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org