Manaʻo ʻia ka hoʻāʻo e hoʻokaʻawale i nā maʻi transplant kidney 64 kiʻekiʻe loa me kahi cPRA o ≥99.9%, e hōʻike ana i kahi ʻāpana o nā maʻi maʻi koʻikoʻi e hoʻomau nei i ka hemahema ʻoiai ʻo ka prioritization ma lalo o ka US kidney allocation system. Ke loaʻa kahi okana hāʻawi a hōʻike ʻia kahi crossmatch maikaʻi me ka mea i manaʻo ʻia ʻaʻole kūpono ke kino, e hoʻokaʻawale ʻia ka mea maʻi i ka lāʻau desensitization imlifidase a i ʻole i kahi lima hoʻomalu e loaʻa i ka maʻamau o ka mālama (ʻo ia hoʻi ke kali ʻana i kahi mea kūpono. ka hāʻawi ʻana a i ʻole ka loaʻa ʻana o kahi lapaʻau desensitization hoʻokolohua). ʻO ka hopena mua o ka haʻawina no ka imlifidase e loiloi i ka pōmaikaʻi i ka hoʻololi ʻana i nā maʻi i ʻike nui ʻia ʻo ia ka hana graft kidney ma 12 mahina, ana ʻia e eGFR (estimated Glomerular Filtration Rate).
Hoʻopili ʻia nā pahuhopu o ka hoʻāʻo ʻo ConfIdeS me ka "Advancing American Kidney Health" ("AAKH") US Executive Order (https://kidney360.asnjournals.org/content/1/6/557), aia ma kahi o ʻekolu ākea ākea. nā pahuhopu: (1) hoʻemi i ka pilikia o ka hōʻino ʻana o ke kīkī; (2) hoʻomaikaʻi i ke komo ʻana a me ka maikaʻi o nā koho lapaʻau pili kanaka; a me (3) e hoʻonui ana i ka loaʻa ʻana o ka hoʻololi ʻana i nā kīkī, me nā mea hope ʻelua i pili pono i ka hoʻonui ʻana i ka transplantation.
Ua koho ʻia ʻo Robert A. Montgomery, MD, Polofesa o ke ʻoki a me ka Luna Hoʻokele, NYU Langone Transplant Institute ma New York City, i National Coordinating Investigator no ka hoʻokolokolo ConfIdeS. E hoʻopaʻa inoa ka hoʻokolokolo i nā poʻe maʻi ma 12 a 15 mau kikowaena transplantation alakaʻi i ka US
Manaʻo ʻia ka pau ʻana o ke kākau inoa ʻana i ka hoʻokolokolo ma ka hapa ʻelua o 2022, me kahi manawa noiʻi he 12 mau mahina i manaʻo ʻia e hoʻopau ʻia i ka hapa ʻelua o 2023. Manaʻo ʻia nā hopena mai kēia hoʻokolokolo pivotal e kākoʻo i kahi waiho BLA ka FDA ma lalo o ke ala ʻae wikiwiki i ka hapa mua o 2024.
Ua loaʻa ʻo Imlifidase i ka ʻae kūʻai kūʻai kūlana ma ʻEulopa no ka mālama desensitization o nā maʻi maʻi hoʻololi kiʻekiʻe kiʻekiʻe o ke kanaka makua me ka crossmatch maikaʻi e kūʻē i kahi mea hāʻawi make i loaʻa.
