Sabon Maganin Rage Dashen Koda

A KYAUTA Kyauta 6 | eTurboNews | eTN
Written by Linda Hohnholz

Hansa Biopharma AB a yau ta sanar da cewa majiyyaci na farko a cikin buɗaɗɗen lakabin sa na Amurka, bazuwar, gwaji mai mahimmanci ("ConfIdeS") an yi rajista a Cibiyar Kiwon Lafiya ta Jami'ar Columbia, New York. Gwajin ConfIdeS yana kimanta imlifidase a matsayin yuwuwar maganin rage jin daɗi don ba da damar dashen koda a cikin majinyata masu hankali waɗanda ke jiran kodar mai ba da gudummawa da ta mutu ta hanyar tsarin rarraba koda na Amurka.

Ana sa ran gwajin zai bazu majinyata masu dashen koda na 64 tare da cPRA na ≥99.9%, wakiltar wani yanki na marasa lafiya da ke da hankali sosai waɗanda ke ci gaba da rashin ƙarfi duk da fifiko a ƙarƙashin tsarin rarraba koda na Amurka. Lokacin da sashin mai ba da gudummawa ya samu kuma ingantaccen daidaitawa tare da wanda aka nufa yana nuna cewa sashin bai dace ba, za a keɓance majinyacin zuwa ko dai rashin lafiyar rashin jin daɗi ko kuma ga hannun kulawa wanda zai sami daidaiton kulawa (watau jiran ƙarin dacewa). tayin koda ko karɓar maganin rashin jin daɗi na gwaji). Babban mahimmin ƙarshen binciken don imlifidase don kimanta fa'idar dasawa marassa lafiya sosai shine aikin dasa koda a watanni 12, wanda aka auna ta eGFR (ƙididdigar Glomerular Filtration Rate).

Makasudin gwajin ConfIdeS sun yi daidai da “Ci gaban Lafiyar Koda ta Amurka” (“AAKH”) Umarnin zartarwa na Amurka (https://kidney360.asnjournals.org/content/1/6/557), wanda ke tsakiya kusa da fadi uku. raga: (1) rage haɗarin gazawar koda; (2) inganta samun dama da ingancin zaɓuɓɓukan jiyya na mutum; da (3) kara samun damar dashen koda, tare da biyun na biyun kai tsaye daure da fadada dashen.

Robert A. Montgomery, MD, Farfesa na Tiya da Darakta, NYU Langone Transplant Institute a birnin New York, an nada shi mai bincike na haɗin gwiwar kasa don gwajin ConfIdeS. Gwajin za ta yi rajistar marasa lafiya a manyan cibiyoyin dasawa 12 zuwa 15 a cikin Amurka

Ana sa ran kammala rajista a cikin gwaji a cikin rabin na biyu na 2022, tare da tsawon watanni 12 na bin diddigin ana sa ran kammalawa a cikin rabin na biyu na 2023. Sakamako daga wannan gwaji mai mahimmanci ana tsammanin zai goyi bayan yuwuwar ƙaddamar da BLA zuwa FDA a ƙarƙashin ingantacciyar hanyar amincewa a farkon rabin 2024.

Imlifidase ya riga ya sami amincewar tallace-tallace na sharadi a cikin Turai don rashin jin daɗin jiyya na manya masu fama da dashen koda tare da ingantacciyar daidaituwa da mataccen mai ba da gudummawa.

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Linda Hohnholz

Edita a shugaba don eTurboNews bisa ga eTN HQ.

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