Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior t… (NCT04935177) | Clinical Trial Compass
CompletedPhase 3
Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx
United States64 participantsStarted 2021-10-14
Plain-language summary
An open-label, controlled, randomized Phase 3 trial evaluating 12-month kidney function in highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Signed Informed Consent obtained before any trial-related procedures
* Male or female age 18-70 years at the time of screening
* Chronic kidney disease (CKD) stage 5, highly sensitized as evaluated by standard selection criteria, and active on the OPTN waiting list for a DD kidney transplant
* Original calculated panel reactive antibody (cPRA) ≥99.9%
* Virtual crossmatch (vXM), predictive of a positive crossmatch to an available deceased donor (DD)
* Willingness and ability to comply with the protocol
* Willingness to participate in the planned 4-year extension trial
Exclusion Criteria:
* High dose IVIg (2 g/kg) treatment within 28 days prior to imlifidase treatment
* Previous treatment with imlifidase
* Breast feeding or pregnancy
* Women of child-bearing potential not willing or able to practice FDA-approved forms of contraception, or abstinence. 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 or A2B kidneys wil…
What they're measuring
1
Mean estimated glomerular filtration rate (eGFR) at 12 months