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Article History

Received: 30 November 2025

Accepted: 1 April 2026

First Online: 9 May 2026

Declarations

:

: Chaim Roifman was previously DSMB Chair for the Kedrion KB070 study (role now ended). William Lumry reports consultancy, speaking, and research support with AstraZeneca, BioCryst, CSL Behring, Kalvista, Ionis, Novartis, and Takeda; consultancy with Astria, Express Scripts/CVS, Intellia, Pharvaris, and Novartis; and research support from Astria, Biomarin, Intellia, Kedrion, Lilly, Pharvaris, Teva, and Up Stream Bio. Richard L. Wasserman reports Investigator for ADMA, GC Biopharma, Kedrion, and Takeda; consultant for Evolve Biologicals, GC Biopharma, and Takeda; and speaker for CSL Behring, Grifols, and Takeda. Syed Rehman reports being speaker for AstraZeneca and Takeda; and research as Principal Investigator with AstraZeneca, Sanofi, GSK, Pfizer, Evvomune, Celldex, Takeda, Chessi, Teva, and Winword. Heather Lehman reports research as site Principal Investigator with Sanofi, Novartis, and Chiesi. Miranda Norton, Mirella Calcinai, and Aaron Kleyn are employees of Kedrion S.p.A. Elena Perez reports activities as Principal Investigator, co-Principal Investigator, or sub-investigator for clinical trials for Grifols, Kedrion, Green Cross, ADMA, Takeda, CSL Behring, Aimmune, ALK, Therapure Biopharma, and Prometic; consultant and speaker (currently) for Grifols and CSL Behring. Donald McNeil, Henry Kanarek, James Moy, Tina Zecca, and Jason Raasch have nothing to disclose.

: This study (NCT03961009; short title: CARES10, Clinical Assessment of phaRmacokinetics, Efficacy, and Safety of 10% IVIg in PID patients) was conducted in accordance with the accepted version of the Declaration of Helsinki in compliance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and according to the appropriate regulatory requirements in the countries where the study was conducted. All sites except Rush University Medical Center received ethical approval for the study by Copernicus Group Institutional Review Board, IRB number 20190538. For the site under Rush University Medical Center, ethical approval was provided from the Rush University Medical Center Institutional Review Board, IRB number 19011803-IRB01. A data safety monitoring board, independent of the sponsor and investigators, was established for this study. The board periodically monitored, reviewed, and evaluated the safety and efficacy data, and reviewed specific adverse events to determine whether they met the criteria for acute serious bacterial infections. Signed informed consent was obtained from all subjects screened for inclusion in the study.