Post Approval Study of Lixelle for the Treament of Dialysis-Related Amyloidosis

Launched by KANEKA MEDICAL AMERICA LLC · Oct 30, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Lixelle® for patients with dialysis-related amyloidosis (DRA), a serious condition that can develop when someone has been on long-term hemodialysis. DRA happens when a substance called β2-microglobulin builds up in the blood because the kidneys are not able to remove it properly. This buildup can lead to painful symptoms and complications in the bones and joints. Lixelle® is designed to help remove this substance from the blood during dialysis sessions, potentially relieving symptoms and improving daily life for patients.

To participate in this trial, patients must be receiving hemodialysis three times a week and have been diagnosed with DRA based on certain medical tests or symptoms. For instance, they might have had a biopsy that shows amyloid fibrils or have specific joint issues. However, there are some people who cannot participate, such as those with certain other health conditions or those planning to become pregnant. Participants can expect to receive the Lixelle® treatment during their regular dialysis sessions and will be monitored for improvements in their symptoms. This study aims to gather more information about the effectiveness and safety of Lixelle® in treating DRA.

Gender

ALL

Eligibility 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