RecruitingPhase 2NCT05753930

Imlifidase Prior to Kidney Transplant in Highly Sensitised Children

A Single-arm, Multi-centre Trial to Evaluate Efficacy and Safety of Imlifidase in Highly Sensitised Children (1-17 Years) Receiving a Kidney Transplant With Positive Crossmatch Against a Living or Deceased Donor Converted to Negative After Imlifidase Treatment


Sponsor

Hansa Biopharma AB

Enrollment

10 participants

Start Date

Jun 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn about the efficacy and safety of imlifidase in highly sensitized paediatric patients, 1-17 years old, with end stage renal disease (ESRD). The main questions it aims to answer are: * Does imlifidase treatment result in crossmatch conversion that enables transplantation? * How is the function of the transplanted kidney? The participants will be hospitalised in accordance with the normal routines for transplanted patients. The patients will receive medication to prevent rejection of the donor kidney, and because such treatment make the body more vulnerable medications to prevent infections.


Eligibility

Min Age: 1 YearMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing imlifidase, an enzyme that temporarily removes certain antibodies from the blood, in highly sensitized children waiting for a kidney transplant. This could make it possible for these children to receive a transplant from donors they previously could not accept due to immune incompatibility. **You may be eligible if...** - You (or your child) are between 1 and 17 years old - You have end-stage kidney disease and are waiting for a kidney transplant - You have very high levels of antibodies (panel reactive antibodies ≥80%) that make it hard to find a compatible donor - A parent or guardian (and the patient, where age-appropriate) has given informed consent **You may NOT be eligible if...** - You (or your child) are 18 or older - Antibody levels are not high enough to qualify - You do not have end-stage renal disease requiring a transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGImlifidase

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.


Locations(5)

HUS, Helsinki University Hospital

Helsinki, Finland

Robert Debre University Hospital

Paris, France

Hospital Unviersitari Vall d'Hebron, Nefrología Pediátrica

Barcelona, Spain

Karolinska University Hospital

Huddinge, Stockholm County, Sweden

Great Ormond Street Hospital for Children NHS Foundation Trust

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05753930