Trial reportAdvances in therapy2026
Clinical Evaluation of Pharmacokinetics, Efficacy, and Safety of a 10% Immunoglobulin in Primary Immunodeficiency Disease (CARES10 Study).
Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03961009 (A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety and Pharmacokinetics of Kedrion Intravenous Immunoglobulin), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety and Pharmacokinetics of Kedrion Intravenous Immunoglobulin (IVIg) 10% in Primary Immunodeficiency Disease (PID) Patients
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionDifferential tolerability and side effects of intravenous immunoglobulin G (IVIg) therapy to treat primary immunodeficiency (PI) have resulted in an unmet need for alternative treatment options. This study was conducted to evaluate the safety and efficacy of a newly formulated IVIg, Kedrion IVIg 10% (KIg10).
methodsThe CARES10 (Clinical Assessment of phaRmacokinetics, Efficacy, and Safety of 10% IVIg in PID patients) study was a phase III, open-label, prospective, single-arm, historically controlled, multicenter study of KIg10 (200-800 mg/kg) in previously treated patients with PI.
resultsA total of 47 patients with PI were enrolled in the study and received infusions of KIg10 on a 21- or 28-day dosing schedule for a period of 48 weeks. All study participants completed the trial, and 44 of the 47 reached the maximum allowed infusion rate for the study. No acute serious bacterial infections (SBI) were reported. All patients had post-baseline IgG trough levels of ≥ 6 g/L at all study visits, except for one patient at a single visit, and all patients maintained IgG subclass distributions comparable to those in healthy subjects. KIg10 pharmacokinetics were measured in a subset of patients (n = 23). The primary adverse events observed were similar in frequency to other IVIg products and did not raise any safety concerns.
conclusionKIg10 was well tolerated and effective for treating patients with PI, and presents a potential additional therapeutic option for treating patients with PI.
trial registrationClinicalTrials.gov identifier, NCT03961009.
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