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Device

Lixelle® for Dialysis Amyloidosis

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)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial is for a treatment that removes a molecule produced by most cells in the body from HD patients' blood to help prevent a serious complication. It has been used since 1996 in Japan to improve daily living and reduce joint pain.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

the rate of SAE

Secondary outcome measures

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

Hypesthesia

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kaneka Medical America LLCLead Sponsor

11 Previous Clinical Trials

664 Total Patients Enrolled

Jeffrey Silberzweig, MDPrincipal InvestigatorThe Rogosin Institute

1 Previous Clinical Trials

79 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any participants currently being enrolled in this research endeavor?

"Data hosted on clinicaltrials.gov corroborates that this medical trial, which was first advertised in October 2015, is not actively recruiting. However, 104 other trials requiring patient participation are still accepting applications right now."

Answered by AI