Lixelle® for Dialysis Amyloidosis

Overseen by Jeffrey Silberzweig, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kaneka Medical America LLC

Disqualifiers: Rheumatoid arthritis, Osteoporosis, Osteoarthritis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Lixelle® for dialysis-related amyloidosis?

Research shows that Lixelle® treatment helps improve symptoms like joint pain and sleep disturbances in patients with dialysis-related amyloidosis by removing a harmful protein called beta2-microglobulin from the blood. Most patients reported that their symptoms did not worsen, and many felt overall improvement, according to surveys and clinical trials. ^{1 2 3 4 5}

How does the Lixelle treatment differ from other treatments for dialysis-related amyloidosis?

Lixelle is unique because it is a direct hemoperfusion column specifically designed to remove beta2-microglobulin from the blood, which is a key factor in dialysis-related amyloidosis. Unlike other treatments, Lixelle uses porous cellulose beads to selectively adsorb beta2-microglobulin and inflammatory cytokines, helping to improve symptoms like joint pain and sleep disturbances. ^{1 2 3 4 5}

Research Team

Jeffrey Silberzweig, MD

Principal Investigator

The Rogosin Institute

Eligibility Criteria

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.

Inclusion Criteria

I am on thrice-weekly hemodialysis and diagnosed with DRA.

My biopsy showed amyloid deposits consistent with β2M.

I have been diagnosed with two or more of the following: joint pain, carpal tunnel, trigger finger, dialysis-related back issues, or bone cysts not caused by other diseases.

Exclusion Criteria

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

Patient planning to become pregnant, pregnant, or breast-feeding

I have been diagnosed with rheumatoid arthritis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lixelle® treatment for dialysis-related amyloidosis over a period of 2 years

104 weeks

Regular visits during each dialysis session

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lixelle® treatment (Device)

Trial Overview 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.

Participant Groups

Group I: Lixelle® treatment Experimental Treatment 1 Intervention

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

Group II: natural history Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Kaneka Medical America LLC

Lead Sponsor

Trials

13

Recruited

720+

Findings from Research

A nationwide survey involving 345 patients treated with Lixelle for dialysis-related amyloidosis showed that 84.9-96.5% of patients reported that their symptoms worsened less frequently, indicating significant therapeutic efficacy.

Physicians also supported these findings, with 72.8% evaluating Lixelle treatment as effective or partially effective, suggesting that Lixelle can be a valuable treatment option for managing this serious complication of long-term hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of the effects of a column for adsorption of β2-microglobulin in patients with dialysis-related amyloidosis in Japan. Gejyo, F., Amano, I., Ando, T., et al.[2015]

The Lixelle column effectively removes beta2-microglobulin from the blood of patients with dialysis-related amyloidosis, leading to significant improvements in symptoms like reduced nocturnal awakenings and joint pain.

While the treatment shows promise, hypotension is a common side effect, highlighting the need for further research to understand both its efficacy and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New adsorption column (Lixelle) to eliminate beta2-microglobulin for direct hemoperfusion. Furuyoshi, S., Nakatani, M., Taman, J., et al.[2019]

Lixelle S-35 effectively removes beta2-microglobulin from the blood, improving symptoms of dialysis-related amyloidosis (DRA) such as joint pain and nocturnal awakening, based on its larger column volume of 350 mL.

Lixelle S-15, with a smaller column volume of 150 mL, can achieve similar beta2-microglobulin removal when paired with a high-clearance dialysis membrane, and it has fewer adverse effects like hypotension and decreased hematocrit compared to S-35, while still improving joint pain over a 6-month treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beta2-microglobulin-selective adsorbent column (Lixelle) for the treatment of dialysis-related amyloidosis. Suzuki, K., Shimazaki, M., Kutsuki, H.[2019]

Lixelle is an effective treatment for dialysis-related amyloidosis (DRA), significantly reducing levels of beta2-microglobulin and inflammatory cytokines, which helps improve symptoms like joint pain and daily activities in hemodialysis patients.

In vitro studies show that Lixelle can eliminate over 1 mg of beta2-microglobulin per milliliter of its adsorbent beads, demonstrating its strong capacity for selective adsorption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

beta(2)-Microglobulin-selective direct hemoperfusion column for the treatment of dialysis-related amyloidosis. Kutsuki, H.[2016]

In a study of 39 hemodialysis patients treated with the β(2)-microglobulin adsorption column (Lixelle), there was a significant reduction in the number and area of bone cysts in the wrist joints, indicating its efficacy in treating dialysis-related amyloidosis (DRA).

Clinical symptoms associated with DRA also improved significantly in patients receiving Lixelle treatment, highlighting its potential benefits beyond just radiographic changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of β(2)-microglobulin adsorption column in treating dialysis-related amyloidosis: a multicenter study. Kuragano, T., Inoue, T., Yoh, K., et al.[2016]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Survey of the effects of a column for adsorption of β2-microglobulin in patients with dialysis-related amyloidosis in Japan. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

New adsorption column (Lixelle) to eliminate beta2-microglobulin for direct hemoperfusion. [2019]

3. Australia pubmed.ncbi.nlm.nih.gov

Beta2-microglobulin-selective adsorbent column (Lixelle) for the treatment of dialysis-related amyloidosis. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

beta(2)-Microglobulin-selective direct hemoperfusion column for the treatment of dialysis-related amyloidosis. [2016]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of β(2)-microglobulin adsorption column in treating dialysis-related amyloidosis: a multicenter study. [2016]