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Contact Information:

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Be Part of Research - Trial Details - Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts

Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts

Recruiting

Open to: ALL

Age: 18.0 - 75.0

Medical Conditions


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


An open-label post authorization efficacy and safety study evaluating graft failure-free survival at 1-year in highly sensitized end-stage renal disease (ESRD) patients with positive crossmatch (XM) against a deceased donor prior to desensitized with imlifidase and subsequent kidney transplantation. Two non-comparative reference cohorts are included to assess the impact of differences in post-transplantation management and outcome in less sensitized patients.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Apr 2022 Dec 2024

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : 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.

Intervention Arm Group : Imlifidase;

Intervention Type : OTHER
Intervention Description : Transplantation and pre- and post-transplantation therapies in accordance with the clinic's normal transplantation routine.

Intervention Arm Group : Non-Comparative Concurrent Reference Cohort;Non-Comparative Historical Reference Cohort;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Leicester General Hospital
    Leicester
    LE5 4PW
  • St. James University Hospital
    Leeds
    LS9 7TF


The study is sponsored by Hansa Biopharma AB




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Read full details for Trial ID: NCT05369975
Last updated 30 October 2024

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