The current study is being conducted to assess the efficacy and safety of KIg10 (Intravenous Human Immune globulin 10%) at two different dosages as maintenance therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) following 21 weeks of treatment.
Male or female, aged ≥18 years.
Written informed consent and authorization to access personal health information obtained independently from participants indicating that they understand the purpose of, and procedures required for, the study and are willing to participate.
Documented diagnosis of CIDP consistent with the 2021 European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria.
Current or documented history of significant disability, as defined by an overall INCAT disability score between 2 and 9. A score of 2 must be exclusively from the lower extremities.
Patients' incapable of giving informed consent.
Pure sensory and other CIDP variants.
Females who are pregnant, breastfeeding, unwilling to practice effective birth control methods as defined in Appendix C throughout the study, or planning a pregnancy during the study.
IG-experienced participants requiring an IGIV dosage of more than 1.4 g/kg/month OR SCIG pre-treated participants requiring a SCIG dosage of more than 1.6 g/kg/month.