Nanoparticle for DSA Removal

University of Zurich (UZH)

Status: Active, not recruiting

Conditions: Kidney Failure; Presence of Donor Specific Antibodies

Study type: Observational

Funder types: Other

Identifiers

NCT04277377

2020-00295

Details and patient eligibility

About

Magnetic nanoparticles, coated with human leukocyte antigens (HLA) to capture anti-HLA antibodies with donor specificity (donor-specific antibodies, DSA), will be tested ex-vivo.

Full description

This project aims at developing a new method using human leukocyte antigens (HLA)-coated magnetic nanoparticles to remove donor-specific antibodies (DSA) from the patients' blood ex vivo, while trying to keep the blood unaffected after exposure to the particles.

Nanoparticles will be engineered and tested ex vivo. While nanoparticles were successfully coated with macromolecules such as antibodies in the past, this is a new approach, which will be performed by the research group.

The goal of this project is to capture DSA in patient blood ex vivo and to remove them by magnetic separation. Efficacy and safety of this procedure will be assessed, especially the interaction of these novel particles with other blood components such as coagulation factors or effector cells, which could produce inflammatory mediators. According analyses are initiated and carried out.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• DSA in the blood as detected by Luminex®
• Adults (>18 years old)
• Informed written consent

Exclusion criteria

• Inability to follow the procedures of the study, due to language problems, psychological disorders, social conditions or dementia
• Pregnancy and/or breast feeding
• Unwillingness to participate in this study

Trial design

100 participants in 1 patient group

DSA in patients with kidney failure

Description:

Patients on kidney transplantation waiting list with DSA detected by Luminex (and mean fluorescence intensity (MFI) \> 1000) in their blood.