Nanoparticle for DSA Removal

Recruiting

• Conditions: Kidney Failure; Presence of Donor Specific Antibodies

• Registration Number: NCT04277377
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-20
• Study Start: 2021-10-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of DSA removed in a blood sample using HLA-coated magnetic nanoparticles	1 day	Quantification of DSA removal using HLA-coated magnetic nanoparticles in comparison with blood treated with control nanoparticles (without HLA coating).

Secondary Outcome Measures

Name	Time	Method
Inflammatory blood mediators (IL-6, MCP-1) before and after treatment with HLA-coated magnetic nanoparticles	1 day	Inflammatory parameters as described will be evaluated in blood samples. The same analyses will be repeated after exposure to HLA-coated magnetic nanoparticles.
Blood coagulation (rotational thromboelastometry ROTEM, plasma clotting time) before and after treatment with HLA-coated magnetic nanoparticles	1 day	Coagulation parameters as described will be evaluated in blood samples. The same analyses will be repeated after exposure to HLA-coated magnetic nanoparticles.

Trial Locations

Locations (1)

University Hospital Zurich, Division of Anaesthesiology; 🇨🇭 Zurich, ZH, Switzerland