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Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx

NCT04935177 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-04-30

No results posted yet for this study

Summary

An open-label, controlled, randomized Phase 3 trial evaluating 12-month kidney function in highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care

Conditions

  • Kidney Transplantation in Highly Sensitized Patients

Interventions

DRUG

Imlifidase

Imlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly selective towards IgG. The cleavage of IgG generates one F(ab')2- and one homodimeric Fc-fragment and efficiently neutralizes Fc-mediated activities of IgG.

PROCEDURE

PLEX

PLEX is performed according to the respective site's standard procedure for desensitization.

DRUG

IVIg

IVIg prepared from a pool of immunoglobulins from the plasma of thousands of healthy donors is administered in accordance with respective site's standard procedure for desensitization.

DRUG

Anti-CD20 antibodies

Rituximab and other anti-CD20 according to the respective site's standard procedure for desensitization.

DRUG

Eculizumab

Eculizumab according to the respective site's standard procedure for desensitization.

OTHER

Remain on wait list

Remain on wait list for a more compatible organ offer if desentization with institutional protocol is not appropriate

Sponsors & Collaborators

  • Hansa Biopharma AB

    lead INDUSTRY

Principal Investigators

  • Clinical Operations · Hansa Biopharma AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2025-06-20
Completion
2025-06-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04935177 on ClinicalTrials.gov