Belatacept in Heart Transplantation

What is the Purpose of this Study?

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) > ISHLT 2R, hemodynamic compromise rejection in the absence of a biopsy or histological rejection, re-transplantation, and death at 18 months post-transplant. The secondary clinical objective is to evaluate the effect of NULOJIX® (belatacept) with gradual tacrolimus withdrawal over 9 months on kidney function, HLA antibodies, and various rejection endpoints. The secondary safety objectives will evaluate the incidence of serious infections, PTLD, malignancies, re-listing or re-transplantation, death, as well as the tolerability of belatacept-based therapy.


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