RecruitingOBSERVATIONAL

Immunoadsorption for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This study is exploring a treatment called 'immunoadsorption' (IA) for a rare nerve condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP causes muscle weakness and numbness, affecting the protective layer around nerves. Researchers want to see how safe and effective IA is compared to commonly used treatments like IVIg (intravenous immunoglobulins) and methylprednisolone. The study will involve about 140 patients in Germany and will be observational, meaning doctors will watch how patients do when they switch to IA if their current treatment isn't working well enough. IA is a method to remove harmful antibodies from the blood, similar to another treatment called plasma exchange but with potentially fewer side effects. This research aims to understand if IA could be a helpful option for CIDP patients, particularly those who haven't improved with other therapies.

At a glance

Status

Recruiting

Sponsor

University of Ulm

Enrolment target

140

Start

27 Aug 2025

Estimated completion

27 Aug 2029

Chronic Inflammatory Demyelinating Polyneuropathy

What is this study about?

Chronic Inflammatory Demyelinating Polyneuropathy, or CIDP, is a long-term condition where your body's immune system mistakenly attacks the protective covering of your nerves. This can lead to muscle weakness, numbness, and tingling, making everyday tasks difficult. Currently, treatments like intravenous immunoglobulins (IVIg) or methylprednisolone (a steroid) are often used first, and sometimes plasma exchange (PE) is an option.

This study is looking at a different treatment called 'immunoadsorption' (IA). IA is a bit like cleaning your blood. It works by taking your blood out of your body, passing it through a special filter that removes specific harmful antibodies (proteins that cause the immune system attack), and then returning your 'cleaned' blood. The main difference between IA and PE is that IA is more specific, removing only the problem antibodies and leaving other important blood components. This is thought to make IA safer and better tolerated, with fewer side effects like bleeding problems, compared to PE.

The main goal of this research is to find out if IA can be a safe and effective treatment for people with CIDP, especially those who haven't improved enough with IVIg or methylprednisolone, or who experience too many side effects from those treatments. The study will closely watch about 140 patients over 18 months, observing how they respond if they switch to IA. This isn't a study where specific treatments are given to different groups; instead, doctors will observe how patients who are already receiving or starting IVIg or methylprednisolone, and then switch to IA if needed, fare with their condition.

Key takeaways

This study evaluates immunoadsorption (IA) for CIDP.
It's for people not responding to standard CIDP treatments (IVIg/methylprednisolone).
IA filters harmful antibodies from your blood, potentially with fewer side effects than other treatments.
The study is observational, watching how patients do over 18 months.
It aims to see if IA is a safe and effective 'escalation' option for CIDP.
You must be 18 or older and currently on or starting IVIg/methylprednisolone to be eligible.

Who may be eligible?

To take part in this study, you would need to have been diagnosed with CIDP based on specific medical guidelines. You must also be 18 years old or older.

You would need to be currently receiving or about to start treatment with either IVIg or methylprednisolone. It's really important that you understand what the study involves and are happy to give your written permission to participate.

There are no specific reasons that would automatically stop you from joining this study, as long as you meet the conditions above.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I been diagnosed with CIDP according to official guidelines?
Am I 18 years old or older?
Am I currently receiving or about to start IVIg or methylprednisolone for my CIDP?
Do I understand what the study involves and am I willing to give my consent?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be observed for 18 months. You'll start the study while continuing your current treatment with IVIg or methylprednisolone. If your doctor determines that your current treatment isn't working well enough, or if you're having significant side effects, you might switch to immunoadsorption (IA).

IA involves a procedure where your blood is gently drawn, filtered to remove harmful antibodies, and then returned to you. The number of IA sessions, how much blood is filtered, and how often this happens will be decided by your care team at the hospital. These decisions will typically follow general recommendations, but your doctor will tailor them to your individual needs.

You will have check-up appointments every six months. During these visits, your medical team will collect important information about your health and how you're responding to treatment. The total duration of your active participation in collecting this data will be 18 months.

Potential risks and benefits

This study aims to understand if immunoadsorption could offer a new or better treatment option for CIDP, especially for those not responding to current therapies. While the exact benefits for you are not guaranteed, this research could help improve understanding and future treatments for CIDP. IA is generally considered a low-risk procedure, as it's designed to be safer than some similar treatments by not removing all blood components. However, like any medical procedure, there can be some risks, although usually minor. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

University of Ulm
Verified postcode
Ulm, Germany· Recruiting

Common questions

What is CIDP?

CIDP is a long-term condition where your immune system attacks the protective covering of your nerves, leading to weakness and numbness.

What is immunoadsorption (IA)?

IA is a treatment that filters your blood to remove harmful antibodies that are attacking your nerves, then returns the 'cleaned' blood to you.

Why is this study being done?

Researchers want to see if IA is a safe and effective treatment for CIDP, especially for people who haven't fully responded to other common treatments.

Will I have to stop my current CIDP treatment?

No, you will start the study on your current IVIg or methylprednisolone treatment. You may switch to IA later if your current treatment isn't working well enough.

Is IA a new treatment?

IA is an existing medical procedure, but its benefits for CIDP, particularly in comparison to other existing treatments, are still being carefully studied.

How to find out more

Johannes Dorst, Prof. Dr.

johannes.dorst@uni-ulm.de +497311775285 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.