Daratumumab-SC for Highly Sensitized Patients Awaiting Heart Transplantation

Part of paid clinical trials in Stanford, California.

Sponsor
Ronald Witteles
Study ID
NCT04610320
Phase
PHASE1
Status
Completed

Conditions

  • Allosensitization
  • Heart Transplant Failure and Rejection

Eligibility Criteria

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

Interventions

  • Daratumumab-SC — DRUG
    \>Daratumumab-SC 1800 mg subcutaneous weekly for 8 doses and then every other week for 2 doses.

Study Details

The purpose of this study is to test whether Daratumumab-SC, a drug that eliminates antibody-producing plasma cells, can effectively lower the level of preformed antibodies in patients awaiting heart transplantation. These preformed antibodies limit the number of donor hearts that are compatible for the patients. If Daratumumab-SC can effectively remove preformed, donor-specific antibodies, then highly allosensitized patients will have more compatible hearts available to them, potentially decreasing transplant waitlist time and reducing mortality.

Key Dates

Start date
Jul 1, 2021
Status verified
Mar 2024
Primary completion
Jan 26, 2024
Completion
Jan 26, 2024

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab-SC Injection
    * Participants will receive a subcutaneous dose of Daratumumab-SC (1800 mg) weekly for 8 doses and then every other week for 2 doses. * Participants will undergo laboratory testing, including for circulating antibodies, at baseline, prior to each infusion session, and at the end of the study.

Primary Outcome Measure

Change in the level of preformed HLA antibodies before and after Daratumumab-SC treatment, based on the absolute difference in PRA levels before and after treatment. [ Time Frame: Baseline and Week 12 (or the last measurement prior to heart transplantation, whichever is earlier). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Health CareStanfordCalifornia94304-

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By research site
Stanford Health Care· Stanford, CA

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