Actively Recruiting
Post Approval Study of Lixelle for the Treament of Dialysis-Related Amyloidosis
Led by Kaneka Medical America LLC · Updated on 2025-04-30
40
Participants Needed
1
Research Sites
582 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Dialysis-related amyloidosis (DRA) is a serious complication of long-term hemodialysis (HD). Its pathogenic mechanism involves accumulation of β2-microglobulin (β2M) in the blood. β2M is produced by most cells in the body and is metabolized in the kidney in healthy individuals. However, in HD patients with renal dysfunction, β2M which is not removed entirely by HD accumulates excessively in the blood. Then it forms amyloid fibrils that are deposited in bones, joints, and soft tissues. The fibrils are further modified by advanced glycation end products (AGE), inducing local macrophage infiltration and production of cytokines leading to chronic inflammation and activation of osteoclasts. Consequently, severe complications with various symptoms are developed, which are collectively referred to as DRA. Lixelle® is a whole-blood β2M apheresis column developed to adsorb and eliminate β2M selectively from the blood of DRA patients. The treatment is performed with Lixelle® connected upstream of the dialyzer in series on a HD circuit in every session. The Lixelle® column contains porous cellulose beads with covalently linked hexadecyl alkyl chain ligands, which selectively adsorb β2M, via a molecular sieving effect because of its porous structure and hydrophobic interaction with ligands. Lixelle® has been used to relieve symptoms and prevent the progression of DRA in Japan since 1996, when health insurance coverage and reimbursement for the treatment were approved by Japanese Ministry of Health, Labor, and Welfare. Improvement of the activities of daily living (ADL) and remission of arthralgia by Lixelle® treatment has been shown in several clinical studies.
CONDITIONS
Official Title
Post Approval Study of Lixelle for the Treament of Dialysis-Related Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients receiving thrice-weekly hemodialysis
- Diagnosis of dialysis-related amyloidosis by one or more of the following:
- Biopsy showing Congo-red positive amyloid fibrils and beta-2-microglobulin staining
- Shoulder ultrasound with rotator cuff thickness over 8 mm or echogenic pads between rotator cuff muscles
- Two or more of polyarthralgia, carpal tunnel syndrome, trigger finger, dialysis-associated spondylosis, or bone cysts (excluding cysts from other diseases)
- Biopsy showing Congo-red positive amyloid fibrils plus one diagnosis or surgical history from the above conditions
You will not qualify if you...
- Diagnosis of rheumatoid arthritis
- Diagnosis of osteoporosis
- Diagnosis of osteoarthritis
- Planning to receive kidney transplant during the study
- Inability to achieve adequate anticoagulation
- Contraindications to extracorporeal circulation therapy such as severe heart failure, recent heart attack, severe arrhythmia, seizures, or uncontrolled blood pressure
- Planning to become pregnant, currently pregnant, or breastfeeding
- Unable to understand or answer questionnaires even with assistance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Rogosin Institute
New York, New York, United States, 10021
Actively Recruiting
Research Team
J
Joanne McLaughlin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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