Treatment of dialysis-related amyloidosis using Lixelle
Treatment of Dialysis-Related Amyloidosis Using Lixelle® β2-microglobulin Apheresis Column
This study is testing if Lixelle can safely help people with dialysis-related amyloidosis feel better compared to regular hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | Kaneka Medical America LLC Industry-sponsored |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT02952144 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of Lixelle®, a whole-blood β2-microglobulin apheresis column, in patients suffering from dialysis-related amyloidosis (DRA). The study involves a prospective double-armed design, with one group receiving Lixelle® treatment for two years and a control group undergoing conventional hemodialysis. The primary focus is on assessing the safety of Lixelle® while secondary objectives include measuring the reduction rate of β2-microglobulin in a single dialysis session. Adverse events will be monitored throughout the treatment period to ensure patient safety.
Who should consider this trial
Good fit: Ideal candidates for this study are patients undergoing thrice-weekly hemodialysis who have been diagnosed with dialysis-related amyloidosis.
Not a fit: Patients who do not have dialysis-related amyloidosis or those who are not receiving hemodialysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of dialysis-related amyloidosis and enhance the quality of life for affected patients.
How similar studies have performed: Previous studies on β2-microglobulin apheresis have shown promise, but this specific approach with Lixelle® is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients receiving thrice-weekly HD and diagnosed as DRA by one or more of the following 1 to 4 will be included. 1. Biopsy of any tissue, showing Congo-red positive amyloid fibrils and immunohistochemical stains consistent with β2M 2. Shoulder ultrasonography showing rotator cuffs greater than 8 mm in thickness, and /or echogenic pads between muscle groups of the rotator cuff 3. Two or more diagnoses of the following (1) to (5) (1) Polyarthralgia (2) Carpal tunnel syndrome (3) Trigger finger (4) Dialysis-associated spondylosis ((i) or (ii)) (i) Destructive spondyloarthropathy (DSA) (ii) Spinal stenosis (5) Bone cysts (Bone cysts considered to be caused by other diseases such as osteoarthritis, aneurysmal bone cysts and unicameral bone cysts should be excluded.) 4. Biopsy of any tissue, showing Congo-red positive amyloid fibrils, and one diagnosis or surgical history of criterion 3- (1) to (5) Exclusion Criteria: * Patient who meets any of the following 1 to 7 will be excluded from the study. 1. Patient diagnosed with rheumatoid arthritis 2. Patient diagnosed with osteoporosis 3. Patient diagnosed with osteoarthritis 4. Patient planning to receive renal transplantation during the study 5. Patient for whom adequate anticoagulation cannot be achieved 6. Patient for whom extracorporeal circulation therapy is contraindicated, such as those with severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute seizure disorder, or severe uncontrolled hypertension or hypotension 7. Patient planning to become pregnant, pregnant, or breast-feeding 8. Patient unable to understand or answer the questionnaires even with a proper assistance
Where this trial is running
New York, New York
- The Rogosin Institute — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Silberzweig, MD — The Rogosin Institute
- Study coordinator: Joanne McLaughlin
- Email: joanne.mclaughlin@kaneka.com
- Phone: (646) 202-3566
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.