Actively Recruiting
Imlifidase Prior to Kidney Transplant in Highly Sensitised Children
Led by Hansa Biopharma AB · Updated on 2026-04-24
10
Participants Needed
5
Research Sites
430 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Imlifidase Prior to Kidney Transplant in Highly Sensitised Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent obtained from patient/parent/legal guardian/independent witness before any trial procedures
- Highly sensitised patient with panel reactive antibodies (PRA) 80% or higher
- Male or female patient between 1 to 17 years old at screening
- Patient with end-stage renal disease waiting for kidney transplant from living or deceased donor
- Patient must be transplantable (including size match) at consent
- Previous unsuccessful desensitisation with plasmapheresis/IVIg/anti-CD20 or difficult anti-HLA antibody status
- Positive crossmatch test against donor by flow cytometry or complement-dependent cytotoxicity, or virtual crossmatch for deceased donors
- Willingness and ability to comply with the protocol as judged by investigator
You will not qualify if you...
- Previous treatment with imlifidase
- Received IVIg treatment within 28 days before imlifidase
- Desensitisation treatments within 1 month prior to transplantation
- Hypersensitivity to imlifidase or related immunosuppressive drugs
- Ongoing serious infections
- Present or history of thrombotic thrombocytopenic purpura or family history
- Severe conditions at transplantation like advanced heart failure, unstable coronary disease, active peripheral vascular disease, hypercoagulable conditions, or oxygen-dependent respiratory disease
- Malignancy within 3 years before transplantation
- ABO incompatible transplantations (except specific A2/A2B kidneys for B recipients)
- Any other investigator-judged reason precluding transplantation
- Breastfeeding or pregnancy
- Fertile women sexually active without adequate contraception during trial
- Suspected or confirmed COVID-19 infection
- Positive HIV serology
- Clinical signs of HBV, HCV, CMV, or EBV infections
- Donor positive for HIV, HBV, HCV, CMV, or EBV when patient is negative
- Active infections judged relevant by investigator
- Tuberculosis or history of tuberculosis
- Use of other investigational agents recently
- Participation in medical device studies
- Mental incapacity or language barriers affecting consent and trial understanding
- Investigator judgment deeming participation impossible for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
HUS, Helsinki University Hospital
Helsinki, Finland, 00290
Withdrawn
2
Robert Debre University Hospital
Paris, France, 75019
Actively Recruiting
3
Hospital Unviersitari Vall d'Hebron, Nefrología Pediátrica
Barcelona, Spain, 08035
Actively Recruiting
4
Karolinska University Hospital
Huddinge, Stockholm County, Sweden, SE-141 86
Actively Recruiting
5
Great Ormond Street Hospital for Children NHS Foundation Trust
London, United Kingdom, WC1N 3JH
Actively Recruiting
Research Team
C
Central Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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