Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT05049850
Eligibility Criteria:
Inclusion Criteria:
* Signed Informed Consent obtained before any trial-related procedures
* Male or female age 18 to 70 years at the time of screening
* Highly sensitized patients registered on the UNOS waiting list for kidney transplantation, with either of the following:
* cPRA ≥ 99.9%
* cPRA ≥ 98% and have been in kidney paired donation or kidney paired exchange programs for at least 1 year
* A positive crossmatch towards a living donor
* Willingness and ability to comply with the protocol
Exclusion Criteria:
* Previous treatment with imlifidase
* Previous high dose IVIg treatment (2 g/kg) within 28 days prior to imlifidase treatment
* Breast-feeding or pregnancy
* Women of child-bearing potential not willing or able to practice FDA-approved forms of contraception. Two medically acceptable methods of highly effective contraception must be used for the duration of the study (e.g. oral, transdermal, intravaginal, injectable or implantable contraceptive; intrauterine device; intrauterine hormone-releasing system; vasectomized partner; bilateral tubal occlusion; or double-barrier method). For a woman to be considered postmenopausal this ascertainment must be made according to medical records and clinical history and may be aided by measurement of elevated postmenopausal serum gonadotropin levels (FSH).
* ABO blood group incompatible transplantations (A2 and A2B kidneys will not be accepted for B recipients)
* Positive serology for HIV
* Clinical signs of HBV, HCV, CMV, or EBV infection
* EBV seronegative or with unknown EBV serostatus
* Positive SARS-CoV-2 tests at any time point from screening to transplantation
* Active tuberculosis
* Ongoing serious infections as judged by the investigator
* Severe other conditions requiring treatment and close monitoring e.g. cardiac failure ≥ grade 4 (New York Heart Association), unstable coronary disease or oxygen dependent respiratory disease
* A history of a proven hypercoagulable condition
* Present, or history of, thrombotic thrombocytopenic purpura (TTP) or known familial history of TTP
* Intake of investigational drugs (other than imlifidase) within 5 half-lives
* Contemporaneous participation in a medical device study
* Known allergy/sensitivity (except local reactions) to imlifidase or to any drug (or the excipients) specified in the protocol
* Known mental incapacity or language barriers precluding 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05049850
Study Brief:
Protocol Section:
NCT05049850