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New treatment option for Kidney Transplantation in Highly Sensitized Patients
Official title Imlifidase Prior to Kidney Transplant in Highly Sensitised Children
ClinicalTrials.gov ID: NCT05753930
What this study is testing
What is Imlifidase?
Imlifidase is an investigational medicine, being studied as a potential treatment for kidney transplantation in highly sensitized patients.
Also referred to as IdeS, HMED-IdeS.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 17
You may be able to join if
- Signed Informed Consent obtained from patient/parent/legal guardian/independent witness (depending on patient's age) before any trial-related...
- 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
- Patient must be transplantable (including size mismatch) at the time of obtaining informed consent for trial participation
You likely can't join if
- 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
See the full eligibility criteria
- Signed Informed Consent obtained from patient/parent/legal guardian/independent witness (depending on patient's age) before any trial-related procedures
- 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
- Patient must be transplantable (including size mismatch) at the time of obtaining informed consent for trial participation
- 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...
- Positive crossmatch (XM) test determined by flow cytometry crossmatch (FCXM) and/or complement-dependent cytotoxicity crossmatch (CDCXM) tests against the donor. For the DD patients, if physical XM tests are not...
- Willingness and ability to comply with the protocol as judged by the investigator
- 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
- At the time of transplantation: severe other condition requiring treatment and close monitoring e.g. cardiac failure ≥ grade 4 (New York Heart Association), unstable coronary disease, active peripheral vascular disease...
- Malignancy within 3 years prior to transplantation
- ABO blood group incompatible transplantations (A2 and A2B kidneys will not be accepted for B recipients)
- Any other reason that, in the view of the investigator, precludes transplantation
- Breast feeding or pregnancy, if applicable
- Woman of fertile age and sexually active without adequate contraceptive measures to avoid pregnancy during the treatment trial period (i.e. up to 6 months after transplantation)
- Suspicion of Covid-19 infection or positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test
- Positive serology for human immunodeficiency virus (HIV)
- Clinical signs of hepatitis B virus (HBV), hepatitis C virus (HCV), cytomegalovirus (CMV), or Epstein Barr virus (EBV) infection
- Donor with positive serology for HIV, HBV, HCV, CMV or EBV to a patient with negative serology (mismatch serology)
- Clinically relevant active infection(s) as judged by the investigator
- Tuberculosis or history of tuberculosis
- Use of other investigational agents within 5 terminal elimination half-lives prior to the transplantation
- Contemporaneous participation in medical device studies
- Known mental incapacity or language barriers precluding patients'/parents'/legal guardians' adequate understanding of the informed consent information and the trial activities
- Inability by the judgement of the investigator to participate in the trial for any other reason
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
- Paris, France
- Barcelona, Spain
- Huddinge, Stockholm County, Sweden
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Finland; Paris, France; Barcelona, Spain; Huddinge, Stockholm County, Sweden; London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.