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Daratumumab-SC for Highly Sensitized Patients Awaiting Heart Transplantation

NCT04610320 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-03-25

No results posted yet for this study

Summary

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.

Conditions

  • Allosensitization
  • Heart Transplant Failure and Rejection

Interventions

DRUG

Daratumumab-SC

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

Sponsors & Collaborators

  • Ronald Witteles

    lead OTHER

Principal Investigators

  • Ronald M Witteles, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2024-01-26
Completion
2024-01-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04610320 on ClinicalTrials.gov