Belatacept in De Novo Heart Transplantation

PHASE2RecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

August 6, 2020

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Heart Transplantation
Interventions
DRUG

Belatacept

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.

DRUG

Tacrolimus

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.

DRUG

Mycophenolate Mofetil

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).

DRUG

Corticosteroid

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.

Trial Locations (2)

10016

RECRUITING

NYU Langone Health, New York

10032

ACTIVE_NOT_RECRUITING

Columbia University, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

NYU Langone Health

OTHER

NCT04477629 - Belatacept in De Novo Heart Transplantation | Biotech Hunter | Biotech Hunter