A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation (NCT05049850) | Clinical Trial Compass
TerminatedPhase 2
A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation
Stopped: Company decision, not due to any safety reason
United States3 participantsStarted 2022-12-16
Plain-language summary
The purpose of this study is to assess whether imlifidase in combination with bortezomib, belatacept, rituximab and IVIg can suppress donor specific antibodies (DSA) and the occurrence of antibody-mediated rejection (AMR) in highly sensitized patients with chronic kidney disease with a positive crossmatch towards their living donor during a period of 3 months from transplantation.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…