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Safety, immunogenicity, pharmacokinetics, and efficacy of the IgG‐degrading enzyme of  Streptococcus pyogenes  (IdeS [imlifidase]) were assessed in a single‐center, open‐label ascending‐dose study in highly sensitized patients with chronic kidney disease. Eight patients with cytotoxic PRAs (median cytotoxic  PRAs  of 64%) at enrollment received 1 or 2 intravenous infusions of IdeS on consecutive days (0.12 mg/kg body weight ×2 [n = 3]; 0.25 mg/kg ×1 [n = 3], or 0.25 mg/kg ×2 [n = 2]). IgG degradation was observed in all subjects after IdeS treatment, with <1% plasma IgG remaining within 48 hours and remaining low up to 7 days.  Mean fluorescence intensity values  of  HLA  class I and  II  reactivity were substantially reduced in all patients, and C1q binding to anti‐ HLA  was abolished. IdeS also cleaved the IgG‐type B cell receptor on  CD 19 +  memory B cells. Anti‐IdeS antibodies developed 1 week after treatment, peaking at 2 weeks. A few hours after the second IdeS infusion, 1 patient received a deceased donor kidney offer. At enrollment, the patient had a positive serum crossmatch ( HLA ‐B7), detected by complement‐dependent cytotoxicity, flow cytometry, and multiplex bead assays. After IdeS infusion (0.12 mg/kg ×2) and when the  HLA ‐incompatible donor ( HLA ‐B7 + ) kidney was offered, the  HLA  antibody profile was negative. The kidney was transplanted successfully.

Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti‐ HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients