Chithandizo Chatsopano Chochotsa Impso Choyimitsa Impso

A GWIRITSANI KwaulereKutulutsidwa 6 | eTurboNews | | eTN
Written by Linda Hohnholz

Hansa Biopharma AB lero alengeza kuti wodwala woyamba ku US otseguka, osasinthika, olamulidwa ndi mayeso ofunikira ("ConfIdeS") adalembetsa ku Columbia University Medical Center, New York. Mayesero a ConfIdeS akuwunika imlifidase ngati njira yothanirana ndi vutolo kuti athe kuyika impso mwa odwala omwe ali ndi chidziwitso chambiri omwe akudikirira impso yomwe wamwalirayo kudzera mu njira ya US yogawa impso.

Mlanduwu ukuyembekezeka kupangitsa odwala 64 okhudzidwa kwambiri opatsira impso omwe ali ndi cPRA ya ≥99.9%, kuyimira kagawo kakang'ono ka odwala omwe ali ndi chidwi kwambiri omwe akupitilizabe kukhala osowa ngakhale akuyikidwa patsogolo pansi pa dongosolo la kugawa kwa impso ku US. Chiwalo chopereka chikapezeka ndipo kulumikizana kwabwino ndi omwe akuyembekezeredwa kukuwonetsa kuti chiwalocho sichikugwirizana, wodwalayo amasinthidwa kukhala chithandizo cha imlifidase desensitization kapena mkono wowongolera womwe udzalandira chisamaliro chokhazikika (ie kuyembekezera kuti igwirizane kwambiri. Kupereka kwa impso kapena kulandira chithandizo choyesera cha deensitization). Mapeto a phunziroli a imlifidase kuti awone phindu poika odwala omwe ali ndi chidwi kwambiri ndi ntchito ya impso pa miyezi 12, yoyesedwa ndi eGFR (yoyerekeza Glomerular Filtration Rate).

Zolinga za kuyesa kwa ConfIdeS zikugwirizana ndi "Advancing American Kidney Health" ("AAKH") US Executive Order (https://kidney360.asnjournals.org/content/1/6/557), yomwe ili pakati pa atatu otakasuka. zolinga: (1) kuchepetsa chiopsezo cha kulephera kwa impso; (2) kupititsa patsogolo mwayi wopezeka ndi ubwino wa njira zothandizira anthu; ndi (3) kuonjezera mwayi woika impso, ndi ziwiri zotsirizirazo zimamangiriridwa mwachindunji ndi kukulitsa kwa kuikidwa kwa impso.

Robert A. Montgomery, MD, Pulofesa wa Opaleshoni ndi Mtsogoleri, NYU Langone Transplant Institute ku New York City, wasankhidwa kukhala National Coordinating Investigator pa mayesero a ConfIdeS. Mlanduwu udzalembetsa odwala m'malo 12 mpaka 15 otsogola ku US

Kutsilizidwa kwa anthu olembetsa kuyesereraku kukuyembekezeka mu theka lachiwiri la 2022, ndipo nthawi yowerengera yotsatiridwa ya miyezi 12 ikuyembekezeka kumalizidwa mu theka lachiwiri la 2023. Zotsatira za mayeso ofunikirawa zikuyembekezeka kuthandizira kuperekedwa kwa BLA FDA pansi pa njira yovomerezeka yowonjezereka mu theka loyamba la 2024.

Imlifidase yalandila kale chilolezo chotsatsa ku Europe chothandizira odwala omwe ali ndi vuto lopatsira impso omwe ali ndi vuto lotsutsana ndi wopereka wakufayo.

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Linda Hohnholz

Mkonzi wamkulu kwa eTurboNews zochokera ku eTN HQ.

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