Phase 2 Chronic Kidney Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• A parent, legal guardian, or independent witness (depending on the child's age) has signed a consent form before any trial-related steps begin.
• The patient has very high levels of antibodies that make transplant matching difficult, with a panel reactive antibody (PRA) level of 80% or higher (confirm with trial site if unsure what this means).
• The patient is between 1 and 17 years old (up to the day before their 18th birthday) at the time of screening.
• The patient has permanent kidney failure (end-stage renal disease) and is on a waiting list for a kidney transplant from either a living or deceased donor.
• Doctors have confirmed the patient is suitable for transplantation at the time of joining the trial, including where there may be a size difference between donor and recipient.
• Previous attempts to reduce the patient's antibody levels (a process called desensitisation, using treatments such as plasmapheresis, IVIg, or anti-CD20 medication) were unsuccessful, or the patient's antibody levels are considered too high for standard desensitisation to work.
• Testing shows the patient's immune system would likely reject the donor kidney, as shown by a positive crossmatch test; for deceased donor transplants where physical testing isn't possible in time, a virtual crossmatch test predicting a positive result may be accepted.
• The patient is willing and able to follow the trial requirements, as assessed by the trial doctor.

Who may not be able to join:

• The patient has previously been treated with the study drug, imlifidase.
• The patient has received IVIg treatment within the 28 days before the imlifidase treatment date.
• The patient has undergone any desensitisation treatment within one month before the planned transplant.
• The patient has a known allergy or sensitivity to imlifidase, any of its ingredients, or other immune-suppressing drugs listed in the trial protocol.
• The patient currently has a serious active infection.
• The patient has a current diagnosis, past history, or a family history of a blood-clotting condition called thrombotic thrombocytopenic purpura (TTP).
• At the time of transplantation, the patient has a serious additional medical condition requiring treatment and close monitoring, such as severe heart failure, unstable heart disease, active blood vessel disease, proven clotting disorders, or a lung condition requiring ongoing oxygen use.
• The patient has had a cancer diagnosis within the three years before transplantation.
• The transplant involves a blood group (ABO) mismatch between donor and recipient (certain kidney types from A2 or A2B donors will not be accepted for patients with blood group B).
• The trial doctor has determined, for any other medical reason, that the patient is not suitable for transplantation.
• The patient is pregnant or breastfeeding (where applicable).
• The patient is a female of childbearing age who is sexually active and not using adequate contraception for the duration of the trial period, up to six months after transplantation.
• The patient is suspected of having COVID-19 or has tested positive for SARS-CoV-2.
• The patient has tested positive for HIV.
• The patient shows signs of active infection with hepatitis B, hepatitis C, cytomegalovirus (CMV), or Epstein-Barr virus (EBV).
• The donor has tested positive for HIV, hepatitis B, hepatitis C, CMV, or EBV, while the patient has tested negative for the same virus (a serology mismatch).
• The patient has any other clinically relevant active infection, as determined by the trial doctor.
• The patient has active tuberculosis or a past history of tuberculosis.
• The patient has taken another investigational (experimental) drug too recently before the transplant, within a timeframe based on how long that drug stays in the body (confirm specific timing with trial site).
• The patient is currently participating in a medical device study at the same time.
• There are known barriers — such as a mental incapacity or language difficulties — that prevent the patient, parent, or legal guardian from fully understanding the consent information and trial activities.
• The trial doctor has determined, for any other reason, that the patient is unable to participate in the trial.

Important: Always verify eligibility with the trial site directly before applying.