Immune Globulin for Chronic Inflammatory Demyelinating Polyradiculoneuropathy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called KIg10, an intravenous immune globulin, to determine its effectiveness for people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition causing muscle weakness and numbness. The research aims to assess the effectiveness and safety of KIg10 as a maintenance therapy by comparing two different doses. Participants may qualify if they have a CIDP diagnosis, experience significant disability from it, and currently rely on treatments like immunoglobulins or corticosteroids. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to help potentially bring a new treatment to market.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions a 'washout period' (time without taking certain medications) for some treatments. It's best to discuss your specific medications with the trial team to see if any changes are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that intravenous immune globulin (IVIG) is generally well-tolerated by patients. In past studies, IVIG effectively reduced disability in people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) compared to a placebo, suggesting it is a safe treatment option for many patients.
However, like any medication, side effects can occur. Some people may experience headaches, fever, or nausea after receiving the treatment. There is also a rare risk of blood clots, which can increase with long periods of rest or a history of clots.
The FDA has already approved IVIG for several other conditions, supporting its safety. Overall, most patients handle the treatment well, and it has a strong safety record in similar conditions.12345Why are researchers excited about this trial's treatment for CIDP?
Unlike the standard treatments for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), which often involve corticosteroids, plasma exchange, or existing immune globulin therapies, the study drug uses a specific formulation of Intravenous Human Normal Immune Globulin (IGIV) 10%. Researchers are excited about this treatment because it offers a new dosing strategy—starting with a high initial loading dose followed by regular maintenance doses. This approach might provide more consistent immune modulation and potentially improve patient outcomes by stabilizing symptoms more effectively and reducing relapses.
What evidence suggests that this trial's treatments could be effective for CIDP?
Research shows that Intravenous Human Immune Globulin (IVIG) 10% can effectively treat Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Studies have found that IVIG improves patient function and reduces disability and symptoms. Previous trials consistently demonstrated that IVIG works well for both sudden and ongoing nerve problems. Specifically, IVIG therapy proved more effective than a placebo in easing CIDP symptoms. This treatment is now a well-known option for managing CIDP symptoms. Participants in this trial will receive either a 1.0 g/kg or 0.5 g/kg dose of IVIG every 3 weeks, following an initial loading dose, to evaluate its effectiveness over 24 weeks.12678
Who Is on the Research Team?
Miranda Norton, PhD
Principal Investigator
Kedrion S.p.A.
Are You a Good Fit for This Trial?
This trial is for individuals with a confirmed diagnosis of CIDP, who experience significant disability and limb weakness. Participants must understand the study and agree to its procedures. They should be dependent on treatments like immunoglobulins or corticosteroids without recent changes in dosage or worsening symptoms.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Wash-out
Participants undergo a wash-out phase to assess functional deterioration
Treatment
Participants receive either 0.5 g/kg or 1.0 g/kg KIg10 at 3-weekly intervals for 21 weeks
Rescue Treatment
Participants who relapse receive 2.0 g/kg KIg10 at 3-weekly intervals for 21 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Intravenous Human Normal Immune Globulin (IGIV) 10%
Trial Overview
The study tests two different doses of KIg10 (Intravenous Human Immune globulin 10%) as maintenance therapy for CIDP over a period of 21 weeks, aiming to evaluate its effectiveness and safety.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
This group will receive, initial loading dose of 2.0 g/kg of Intravenous (IV) KIg10 (Immunoglobulin) infusion followed by 1.0 g/kg of IV KIg10 every 3 weeks.
This group will receive, Initial loading dose of 2.0 g/kg of Intravenous (IV) KIg10 (Immunoglobulin) infusion will be given followed by 0.5 g/kg of IV KIg10 every 3 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kedrion S.p.A.
Lead Sponsor
Citations
NCT06752356 | A Study Investigating Intravenous Human ...
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 ...
The Results of ADVANCE‐CIDP IVIG Trial
IVIG 10% effectively treated CIDP relapse and improved functional abilities. Keywords: chronic inflammatory demyelinating polyradiculoneuropathy ...
Efficacy of Intravenous Immunoglobulin in Neurological ...
A number of randomized controlled trials have shown that IVIG is effective in acute and chronic demyelinating neuropathies, in worsening MG as short-term ...
Intravenous immunoglobulin for chronic inflammatory ...
Multicentre, randomised, open-label trial to compare efficacy and tolerance of prednisone and IVIG In patients with CIDP on a one year follow up (P7.092).
Intravenous immunoglobulin for the treatment of chronic ...
IVIg therapy was statistically superior to placebo in reducing disability and impairment among patients with CIDP.
6.
uhcprovider.com
uhcprovider.com/content/dam/provider/docs/public/policies/index/commercial/immune-globulin-ivig-scig-08012025.pdfImmune Globulin (IVIG and SCIG)
IVIG is beneficial for treatment of a number of neuroimmunologic diseases based upon FDA approval, published practice guidelines, professional ...
7.
labeling.cslbehring.com
labeling.cslbehring.com/PRODUCT-DOCUMENT/US/Privigen/EN/Privigen-Support-Brochure-(CIDP).pdfCIDP Treatment With Privigen Get back to Living your life ...
Important Safety Information. WARNINGS: • Thrombosis (blood clotting) can occur with immune globulin products, including. Privigen. Risk factors may include ...
Statistical Review - GAMMAGARD LIQUID
GGL is an immune globulin infusion (human) 10% (IGI) solution. In the US, it is indicated as replacement therapy for primary humoral ...
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