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

This is an interventional treatment trial for Dialysis Amyloidosis Read More

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