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Study in highly sensitised kidney transplant patients with a high degree of antibodies against the donor's kidney to see the efficacy and safety of imlifidase to temporarily remove the antibodies and enable the transplantation
EU CTIS ID: 2024-511810-18-00
What this study is testing
To determine the 1-year graft failure-free survival in highly sensitised kidney transplant patients, pre-treated with imlifidase to turn a positive crossmatch against a deceased donor negative
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patient aged 18-75 years
- An acceptable kidney transplant from a deceased donor (concurrent reference cohort patients)
- End-stage renal disease with a kidney transplant from a deceased donor (historical reference cohort patients)
- Being transplanted in Europe after 01-Jan-2010 and included in the CTS registry (historical reference cohort patients)
- PRA ≥ 50% (CDC T or B cell PRA, cPRA, or virtual PRA [vPRA]) (historical reference cohort patients)
- Maintenance immunosuppression (intention to treat) with calcineurin inhibitor, mycophenolate mofetil (MMF) and corticosteroids in combination (historical reference cohort patients)
You likely can't join if
- Previous treatment with imlifidase (imlifidase patients)
- Present, or history of, thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP (imlifidase patients)
- Severe other condition requiring treatment and close monitoring e.g. cardiac failure ≥ grade 4 (New York Heart Association), unstable coronary disease or oxygen dependent respiratory disease (imlifidase patients)
- Malignancy within 5 years prior to transplantation (imlifidase and concurrent reference cohort)
- Positive serology for human immunodeficiency virus (HIV) (imlifidase and concurrent reference cohort)
- Clinically relevant active infection(s) (including hepatitis B [HBV], hepatitis C [HCV], cytomegalovirus [CMV], Epstein Barr Virus [EBV], tuberculosis) as judged by the investigator (imlifidase and concurrent reference cohort)
See the full eligibility criteria
Who can join
- Male or female patient aged 18-75 years
- An acceptable kidney transplant from a deceased donor (concurrent reference cohort patients)
- End-stage renal disease with a kidney transplant from a deceased donor (historical reference cohort patients)
- Being transplanted in Europe after 01-Jan-2010 and included in the CTS registry (historical reference cohort patients)
- PRA ≥ 50% (CDC T or B cell PRA, cPRA, or virtual PRA [vPRA]) (historical reference cohort patients)
- Maintenance immunosuppression (intention to treat) with calcineurin inhibitor, mycophenolate mofetil (MMF) and corticosteroids in combination (historical reference cohort patients)
- ABO-compatible deceased donor aged 10-70 years
- End-stage renal disease (ESRD) active on the renal transplant waiting list of a kidney allocation system at the time of screening (imlifidase patients)
- High sensitisation with the highest unmet medical need unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients (imlifidase patients)
- Known DSA against an available deceased donor (imlifidase patients)
- Positive crossmatch test (imlifidase patients)
- Signed Informed Consent obtained before any trial-related procedures (imlifidase and concurrent reference patients)
- Willingness and ability to comply with the protocol (imlifidase and concurrent reference patients)
- Active on the renal transplant waiting list at a participating trial site at the time of screening (concurrent reference cohort patients)
What rules you out
- Previous treatment with imlifidase (imlifidase patients)
- Present, or history of, thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP (imlifidase patients)
- Severe other condition requiring treatment and close monitoring e.g. cardiac failure ≥ grade 4 (New York Heart Association), unstable coronary disease or oxygen dependent respiratory disease (imlifidase patients)
- Malignancy within 5 years prior to transplantation (imlifidase and concurrent reference cohort)
- Positive serology for human immunodeficiency virus (HIV) (imlifidase and concurrent reference cohort)
- Clinically relevant active infection(s) (including hepatitis B [HBV], hepatitis C [HCV], cytomegalovirus [CMV], Epstein Barr Virus [EBV], tuberculosis) as judged by the investigator (imlifidase and concurrent reference cohort)
- Contemporaneous participation in medical device studies (imlifidase and concurrent reference cohort)
- Known mental incapacity or language barriers precluding adequate understanding of the Informed Consent information and the trial activities (imlifidase and concurrent reference cohort)
- Inability by the judgement of the investigator to participate in the trial for any other reason (imlifidase and concurrent reference cohort)
- Patients treated with mTOR (mammalian target of rapamycin) inhibitors (historical reference cohort)
- Patients treated with belatacept (historical reference cohort)
- Female of childbearing potential, not willing to use effective contraception during the 3 weeks following treatment with imlifidase. In the context of this trial, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly (imlifidase patients)
- Use of investigational agents within 5 terminal elimination half-lives prior to the transplantation (imlifidase and concurrent reference cohort)
- Any other reason that, in the view of the investigator, precludes transplantation (imlifidase patients)
- Previous high dose IVIg treatment (2 g/kg) within 28 days prior to imlifidase treatment (imlifidase patients)
- Suspicion of Covid-19 infection or positive SARS-CoV-2 test (imlifidase patients)
- Breast feeding or pregnancy (imlifidase patients)
- Hypersensitivity to the active substance (imlifidase) or to any of the excipients (imlifidase patients)
- Ongoing serious infections (including HBV, HCV, CMV, EBV, tuberculosis) (imlifidase patients)
The study team makes the final eligibility decision.
Where it's taking place
- 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 EU CTIS; the study team decides eligibility.