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Led by Kedrion S.p.A. · Updated on 2026-08-06
161
Participants Needed
3
Research Sites
1 weeks
Total Duration
Researchers are evaluating the effectiveness and safety of two different doses of KIg10, an intravenous human immune globulin 10%, as maintenance therapy for adults with Chronic Inflammatory Demyelinating Polyneuropathy CIDP. This phase 3, double-blind, randomized study focuses on participants who have active CIDP and have already undergone initial treatment. The study aims to compare the outcomes of two dosing regimens following a wash-out period. Participants first enter a wash-out phase lasting up to 12 weeks or until their condition worsens according to a specific disability score. Then, they are randomly assigned to receive either 0.5 gkg or 1.0 gkg doses of KIg10 every three weeks for 21 weeks. Those who experience worsening symptoms during this phase receive a rescue treatment of 2.0 gkg KIg10 at the same intervals for an additional 21 weeks. Initial loading doses of 2.0 gkg KIg10 are given before maintenance dosing in both groups. During the study, participants undergo regular assessments of their disability and muscle strength using established clinical scales. Researchers monitor quality of life, functional improvement, and treatment response throughout the treatment periods. Safety is closely observed, and participants are monitored for up to 24 weeks of treatment, with follow-up visits to evaluate long-term effects. The trial is sponsored by Kedrion S.p.A. and aims to advance knowledge on dosing strategies for CIDP treatment.
CONDITIONS
A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A
Anna Lotti Suffredini
E
Esra Cinar-Jones
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Kedrion S.p.A.
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Investigational: KIg10 1.0 g/kg | Investigational: KIg10 0.5 g/kg | Contextual: Standard‑of‑care IVIg |
|---|---|---|---|
| What it is | Intravenous human normal immune globulin (KIg10) administered at 1.0 g/kg every 3 weeks over 24 weeks | Intravenous human normal immune globulin (KIg10) administered at 0.5 g/kg every 3 weeks over 24 weeks | Standard induction dosing for CIDP typically uses IVIg 2 g/kg over 2–5 days followed by maintenance doses of about 1 g/kg every 3 weeks |
| Role in trial | One of two randomized investigational dosing arms | One of two randomized investigational dosing arms | Not included in this trial, but commonly used in practice as a reference regimen |
| Primary use | Evaluating efficacy and safety of high‑dose KIg10 in CIDP | Evaluating efficacy and safety of low‑dose KIg10 in CIDP | Used as comparator in clinical practice for treating active CIDP |
| Administration | Given intravenously at 1.0 g/kg dose every 3 weeks for up to 24 weeks | Given intravenously at 0.5 g/kg dose every 3 weeks for up to 24 weeks | Induction IVIg typically 2 g/kg total over 2–5 days then maintenance infusions of about 1 g/kg every 3 weeks |
| Evidence status | Efficacy to be assessed in ongoing trial; no results available yet | Efficacy to be assessed in ongoing trial; no results available yet | Efficacy demonstrated in placebo‑controlled randomized trials in CIDP (e.g. ICE study) |
| Important risks | Not yet established in this trial; safety data pending | Not yet established in this trial; safety data pending | Well‑known risks include headache, nausea, thromboembolic events, infusion reactions |
| Important limitations | No active comparator arm, only dose comparison between investigational regimens | No active comparator arm, only dose comparison between investigational regimens | Contextual comparator not randomized within the trial and may differ in practice patterns |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - Up to 12 weeks
Participants are screened for eligibility to participate in the trial.
Visits as needed during wash-out phase
Duration - Up to 42 weeks total (including rescue treatment)
Participants receive an initial loading dose of KIg10, then continue with either 0.5 g/kg or 1.0 g/kg doses every three weeks for 21 weeks. Those who experience worsening symptoms during treatment may receive a rescue dose of 2.0 g/kg KIg10 every three weeks for an additional 21 weeks.
Visits every 3 weeks during treatment phases
Duration - Up to 24 weeks
Participants are monitored to assess treatment effects and safety through regular evaluations using disability and muscle strength scores, quality of life assessments, and other clinical measures up to 24 weeks.
Regular assessments during and after treatment
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Richard A C Hughes, Peter Donofrio, Vera Bril...
https://pubmed.ncbi.nlm.nih.gov/18178525/Kedrion S.p.A.
Lead Sponsor
