Daratumumab in HLA Desensitization Prior to Transplantation

PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

March 31, 2022

Primary Completion Date

August 31, 2025

Study Completion Date

August 31, 2025

Conditions
Cardiac Transplant
Interventions
BIOLOGICAL

Daratumumab and hyaluronidase-fihj

Daratumumab and hyaluronidase-fihj for subcutaneous (under the skin) injection has different dosing and administration instructions compared to daratumumab for intravenous (in the vein) infusion. Daratumumab and hyaluronidase-fihj contains recombinant hyaluronidase, which mimics hyaluronidase, a naturally occurring substance that increases permeability of subcutaneous tissue. This makes it possible for 15 mL containing 1,800 mg of daratumumab to be administered in approximately 3 to 5 minutes. Subjects will receive a 1800mg/30000u injection subcutaneously weekly for a total of 8 doses

Trial Locations (1)

55905

Mayo Clinic Rochester, Rochester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Janssen Biotech, Inc.

INDUSTRY

lead

Barry A. Boilson

OTHER

NCT05300451 - Daratumumab in HLA Desensitization Prior to Transplantation | Biotech Hunter | Biotech Hunter