Phase 2: testing Imlifidase for Kidney Transplantation in Highly Sensitized Patients
The goal of this clinical trial is to learn about the how well it works 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?
Official registry: https://clinicaltrials.gov/study/NCT05753930 · Hansa Biopharma AB · enrollment listed as 10
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Imlifidase. The registry lists allocation as na. The goal of this clinical trial is to learn about the how well it works and safety of imlifidase in highly sensitized paediatric patients, 1-17 years old, with end stage renal disease (ESRD).
They plan to enroll about 10 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: Imlifidase
Primary outcome (registry wording): Proportion of patients with conversion of a positive crossmatch test to negative within 24 hours after start of imlifidase treatment
Who it is for (from inclusion criteria)
- Ages 1 Year to 17 Years
- Highly sensitised patient with panel reactive antibodies (PRA) ≥80%
- Male or female patient between the age of 1 to 17 years (up to the day before the 18th birthday) at the time of screening
- Patient with end-stage renal disease (ESRD) and waiting for a renal transplant from a living or deceased donor
- Patients who have previously undergone desensitisation unsuccessfully with plasmapheresis/IVIg/anti-CD20 or have an anti-HLA antibody status deemed too difficult to make a successful desensitisation (judgement based on physicians' previous experience with similar patients)
- Willingness and ability to comply with the protocol as judged by the investigator
Who the registry excludes
- Previous treatment with imlifidase
- IVIg treatment within 28 days prior to imlifidase treatment
- Desensitisation treatment(s) within 1 month prior to the current transplantation
- Hypersensitivity to the active substance (imlifidase) or to any of the excipients and to other immunosuppressive drugs specified in the protocol
- Ongoing serious infections
- Present, or history of, thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP
- Malignancy within 3 years prior to transplantation
Public study contact (from the registry)
Central Contact
clinicalstudyinfo@hansabiopharma.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
7 listed- HUS, Helsinki University Hospital — Helsinki, Finland (withdrawn)
- Robert Debre University Hospital — Paris, France (recruiting)
- Ospedale Pediatrico Bambino Gesu — Rome, Italy (not_yet_recruiting)
- Hospital Unviersitari Vall d'Hebron, Nefrología Pediátrica — Barcelona, Spain (recruiting)
- Hospital Sant Joan De Deu Barcelona — Barcelona, Spain (not_yet_recruiting)
- Karolinska University Hospital — Huddinge, Stockholm County, Sweden (recruiting)
- Great Ormond Street Hospital for Children NHS Foundation Trust — London, United Kingdom (recruiting)
FAQ about this NCT record
Is NCT05753930 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05753930?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05753930?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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