Belatacept in De Novo Heart Transplantation

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT04477629
Phase
PHASE2
Status
Recruiting
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Conditions

  • Heart Transplantation

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Belatacept — DRUG
    Belatacept will be given in the following way - 10mg/kg IV day 1, 5, end of weeks 2, 4, 8, 12 then 5mg/kg every 4 weeks.
  • Tacrolimus — DRUG
    Non-experimental: Tacrolimus will be given in the following way - trough level at month 1, 10-12ng/mL; month 2-3, 6-10ng/mL; month 4-6, 4-6ng/mL; months 7-9 taper off.
  • Mycophenolate Mofetil — DRUG
    Non-experimental: MMF is part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice at 500-1500mg twice a day (BID) (dosed to tolerance and effect).
  • Corticosteroid — DRUG
    Non-experimental: CS is part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice at a dose no less than 5mg/d.

Study Details

The purpose of this study is to determine if Belatacept is safe to give to adult heart transplant recipients. Belatacept (NULOJIX) is an anti-rejection medication that is available through a prescription from a doctor. In this research study, belatacept is being used in an investigational manner (not for the purpose that it is approved for).

Key Dates

Start date
Aug 6, 2020
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Belatacept
    Participants will receive Belatacept along with an upfront tacrolimus taper Participants will also receive mycophenolate mofetil and corticosteroids are part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice.

Primary Outcome Measure

Number of Major Graft-Related Adverse Events [ Time Frame: Up to 18 months after transplantation ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Columbia UniversityNew YorkNew York10032-
NYU Langone HealthNew YorkNew York10016
Marlena Habal, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Columbia University· New York, NYNYU Langone Health· New York, NY

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