UNyango olutsha lokuTshintshela izintso

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Ibhalwe ngu Linda Hohnholz

I-Hansa Biopharma AB namhlanje ibhengeze ukuba isigulane sokuqala kwi-US evulekileyo-ileyibhile, i-randomized, i-control control pivotal trial ("ConfIdeS") ibhaliswe kwi-Columbia University Medical Centre, eNew York. Ulingo lwe-ConfIdeS luvavanya i-imlifidase njengonyango olunokubakho lwe-densitization ukwenzela ukuba uqhaqho-fakelo lwezintso kwizigulane ezinovakalelo oluphezulu ezilindele umntu ongasekhoyo wezintso ngenkqubo yokunikezelwa kwezintso yase-US.

Ulingo kulindeleke ukuba lwenze ngokungakhethiyo izigulane ezingama-64 zoqhaqho lofakelo lwezintso kunye ne-cPRA ye-≥99.9%, emele i-subset yezigulane ezinovakalelo oluqhubelekayo ukuhleleleka ngaphandle kokubekwa phambili phantsi kwenkqubo ye-US yolwabiwo lwezintso. Xa ilungu le-donor lifumaneka kwaye i-crossmatch efanelekileyo kunye nomamkeli ocetywayo ibonisa ukuba i-organ ayihambelani, isigulane siya kuba yinto ehleliweyo okanye i-imlifidase unyango lwe-desensitization okanye ingalo yokulawula eya kufumana umgangatho wokunakekelwa (oko kukuthi, ukulinda ukuhambelana ngakumbi. unikezelo lwezintso okanye ukufumana unyango lovavanyo lokudambisa). Esona siphelo sophononongo se-imlifidase sokuvavanya inzuzo ekutyaleni izigulana ezinovakalelo oluphezulu kukusebenza kwezintso kwiinyanga ezili-12, kulinganiswe nge-eGFR (uqikelelo lwe-Glomerular Filtration Rate).

Iinjongo zolingo lwe-ConfIdeS zilungelelaniswe ne-“Advancing American Kidney Health” (“AAKH”) uMyalelo oLawulayo wase-US (https://kidney360.asnjournals.org/content/1/6/557), esekelwe kwisithathu esibanzi. iinjongo: (1) ukunciphisa umngcipheko wokungaphumeleli kwezintso; (2) ukuphucula ukufikelela kunye nomgangatho weendlela zonyango ezijoliswe kumntu; kunye (3) nokwandisa ukufikelela kufakelo lwezintso, nezi zimbini zokugqibela zibotshelelwe ngokuthe ngqo ekwandiseni uqhaqho-fakelo.

URobert A. Montgomery, MD, uNjingalwazi wezoTyando kunye noMlawuli, i-NYU Langone Transplant Institute kwisixeko saseNew York, uqeshwe nguPhando weSizwe woLungelelaniso kwilingo le-ConfIdeS. Ulingo luya kubhalisa izigulane kwi-12 ukuya kumaziko e-15 ahamba phambili okutshintshwa kwe-US

Ukugqitywa kobhaliso kulingo kulindeleke kwisiqingatha sesibini sika-2022, kunye neenyanga ezili-12 zokulandelela ixesha lokufunda elilindeleke ukuba ligqitywe kwisiqingatha sesibini sika-2023. Iziphumo ezivela kolu lingo lubalulekileyo kulindeleke ukuba zixhase ukungeniswa kwe-BLA I-FDA phantsi kwendlela yokuvunywa okukhawulezileyo kwisiqingatha sokuqala sika-2024.

I-Imlifidase sele ifumene imvume yokuthengisa enemiqathango eYurophu yonyango lokungabi namvakalelo kwizigulana zoqhaqho-fakelo lwezintso zabantu abadala ezinonxulumano oluqinisekileyo ngokuchasene nomnikezeli okhoyo oswelekileyo.

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Linda Hohnholz

Umhleli oyintloko we eTurboNews esekwe kwi-eTN HQ.

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