What is the mechanism of action of this treatment?

The most common treatments for Dialysis Amyloidosis, such as Lixelle®, work by selectively adsorbing β2-microglobulin (β2M) from the blood. Lixelle® uses porous cellulose beads with hexadecyl alkyl chain ligands to capture and remove β2M, which accumulates in patients undergoing long-term hemodialysis. This is crucial because excess β2M forms amyloid fibrils that deposit in tissues, leading to severe complications. By reducing β2M levels, these treatments prevent amyloid fibril formation, alleviate symptoms, and improve the quality of life for patients with Dialysis Amyloidosis.

What side effects are associated with this type of intervention?

Treatments for Dialysis-Related Amyloidosis (DRA) that involve the selective adsorption of β2-microglobulin (β2M), such as Lixelle®, can have side effects including hypotension, allergic reactions, and infections due to the invasive nature of the procedure. Long-term use may also lead to vascular access complications and the potential recurrence of amyloid deposits if β2M levels are not adequately managed.

What other types of research exist?

A promising novel alternative to Lixelle® for Dialysis-Related Amyloidosis patients is the use of P(HEMA)-Hp cryogels. These cryogels have demonstrated a high adsorption capacity for low-density lipoprotein cholesterol (LDL-C) and exhibit high desorption ratios with no significant decrease in adsorption capacity after multiple cycles. This suggests their potential for efficient and reusable removal of pathological proteins like β2-microglobulin in DRA patients.

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Device

Lixelle® for Dialysis Amyloidosis

Q: What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for treatments similar to Lixelle® in the provided context. Lixelle® is a unique treatment for Dialysis-Related Amyloidosis that selectively adsorbs β2-microglobulin using porous cellulose beads with hexadecyl alkyl chain ligands. It has been used in Japan since 1996 to relieve symptoms and prevent the progression of DRA. Other treatments for DRA focus on improving dialysis techniques and using high-flux synthetic membranes to enhance β2-microglobulin removal.

N/A

Recruiting

Led By Jeffrey Silberzweig, MD

Research Sponsored by Kaneka Medical America LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy of any tissue, showing Congo-red positive amyloid fibrils and immunohistochemical stains consistent with β2M

Biopsy of any tissue, showing Congo-red positive amyloid fibrils, and one diagnosis or surgical history of criterion 3- (1) to (5)

Must not have

Patient planning to receive renal transplantation during the study

Patient diagnosed with rheumatoid arthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up comparison between baseline and 2 years (104 weeks) after lixelle® treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Lixelle®, a special filter used during dialysis to remove a harmful protein from the blood, in patients with dialysis-related amyloidosis. The goal is to see if Lixelle® is safe and effective in reducing symptoms and improving quality of life for these patients. Lixelle® has been used in Japan for many years to treat this condition.

Who is the study for?

This trial is for patients on thrice-weekly hemodialysis diagnosed with Dialysis-Related Amyloidosis (DRA), showing specific symptoms like joint pain, carpal tunnel syndrome, or bone cysts. It's not for those with rheumatoid arthritis, osteoporosis, planning pregnancy or transplant, or who can't do extracorporeal therapy due to severe heart issues.

What is being tested?

The study tests Lixelle®, a blood-cleansing treatment designed to remove β2-microglobulin from the blood of DRA patients during dialysis. The goal is to alleviate symptoms and prevent disease progression by using a special column in the dialysis circuit.

What are the potential side effects?

Potential side effects are not explicitly listed but may include complications related to the hemodialysis process itself or reactions to the Lixelle® column such as low blood pressure, muscle cramps, infection risk at access site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My biopsy showed amyloid deposits consistent with β2M.

Select...

My biopsy showed Congo-red positive amyloid fibrils.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am planning to have a kidney transplant during the study.

Select...

I have been diagnosed with rheumatoid arthritis.

Select...

I cannot undergo treatments involving external circulation due to severe heart issues or uncontrolled blood pressure.

Select...

I have been diagnosed with osteoporosis.

Select...

I cannot be properly treated with blood thinners.

Select...

I have been diagnosed with osteoarthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ comparison between baseline and 2 years (104 weeks) after lixelle® treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~comparison between baseline and 2 years (104 weeks) after lixelle® treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and comparison between baseline and 2 years (104 weeks) after lixelle® treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

the rate of SAE

Secondary study objectives

comparison of β2M reduction rate between Lixelle® treatment and natural history

Hypesthesia

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Lixelle® treatmentExperimental Treatment1 Intervention

2 years of Lixelle® treatment in the patients with dialysis related amyloidosis (DRA)

Group II: natural historyActive Control1 Intervention

2 years of natural history in the patients with dialysis related amyloidosis (DRA)

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Dialysis Amyloidosis, such as Lixelle®, work by selectively adsorbing β2-microglobulin (β2M) from the blood. Lixelle® uses porous cellulose beads with hexadecyl alkyl chain ligands to capture and remove β2M, which accumulates in patients undergoing long-term hemodialysis. This is crucial because excess β2M forms amyloid fibrils that deposit in tissues, leading to severe complications. By reducing β2M levels, these treatments prevent amyloid fibril formation, alleviate symptoms, and improve the quality of life for patients with Dialysis Amyloidosis.

High-flux synthetic versus cellulosic membranes for beta 2-microglobulin removal during hemodialysis, hemodiafiltration and hemofiltration.Beta 2-microglobulin elimination in end-stage renal disease patients on renal replacement therapy.