Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Flavio G. Vincenti

Description

Summary

Some kidney transplant candidates have a very low chance of getting a kidney transplant because their immune systems are "highly sensitized" to most kidney donors. Being "highly sensitized" means that they will likely have to wait a long time (more than 5 years) before an acceptable donor is found for them or, they never receive a compatible donor, and die on waitlist. The purpose of this study is to find out whether two drugs, daratumumab (Darzalex®), and belatacept (Nulojix®), can make these kidney transplant candidates less sensitized, and make it easier and quicker to find a kidney donor for them.

Official Title

A Mechanistically Driven Therapy to Desensitize >98.0% cPRA Patients: Depletion of Plasma Cells With Anti-CD38 and Prevention of B Cell Activation With Costimulation Blockade (ITN090ST)

Details

Keywords

Highly Sensitized Prospective Kidney Transplant Recipients, calculated panel reactive antibodies (cPRA), desensitization therapy, human leukocyte antigen (HLA) desensitization, Daratumumab, Abatacept, Immunoglobulins, Immunoglobulin G, belatacept, Bone marrow aspiration

Eligibility

Location

  • University of California at San Francisco Medical Center accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Flavio G. Vincenti
    Professor, Medicine, School of Medicine. Authored (or co-authored) 286 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Links
Division of Allergy, Immunology, and Transplantation (DAIT) National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network (ITN)
ID
NCT04827979
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 15 study participants
Last Updated