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ENROLLING BY INVITATION
NCT05300451
PHASE2

Daratumumab in HLA Desensitization Prior to Transplantation

Sponsor: Barry A. Boilson

View on ClinicalTrials.gov

Summary

The purpose of this study is to learn about how well the drug daratumumab/hyaluronidase-fihj (DARZALEX Faspro™) helps to lower high levels of HLA (Human Leukocyte Antigen) antibodies in a person waiting for a heart transplant.

Official title: A Phase II Prospective Study Evaluating the Role of Daratumumab in HLA Desensitization Prior to Transplantation

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2022-03-31

Completion Date

2026-08

Last Updated

2025-10-30

Healthy Volunteers

No

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

Locations (1)

Mayo Clinic Rochester

Rochester, Minnesota, United States