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New treatment option for Dialysis Amyloidosis
Official title Post Approval Study of Lixelle for the Treament of Dialysis-Related Amyloidosis
ClinicalTrials.gov ID: NCT02952144
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Patients receiving thrice-weekly HD and diagnosed as DRA by one or more of the following 1 to 4 will be included.
- Biopsy of any tissue, showing Congo-red positive amyloid fibrils and immunohistochemical stains consistent with β2M
- Shoulder ultrasonography showing rotator cuffs greater than 8 mm in thickness, and /or echogenic pads between muscle groups of the rotator cuff
- Two or more diagnoses of the following (1) to (5) (1) Polyarthralgia (2) Carpal tunnel syndrome (3) Trigger finger (4) Dialysis-associated...
- Biopsy of any tissue, showing Congo-red positive amyloid fibrils, and one diagnosis or surgical history of criterion 3- (1) to (5)
You likely can't join if
- Patient who meets any of the following 1 to 7 will be excluded from the study.
- Patient diagnosed with rheumatoid arthritis
- Patient diagnosed with osteoporosis
- Patient diagnosed with osteoarthritis
- Patient planning to receive renal transplantation during the study
- Patient for whom adequate anticoagulation cannot be achieved
See the full eligibility criteria
- Patients receiving thrice-weekly HD and diagnosed as DRA by one or more of the following 1 to 4 will be included.
- Biopsy of any tissue, showing Congo-red positive amyloid fibrils and immunohistochemical stains consistent with β2M
- Shoulder ultrasonography showing rotator cuffs greater than 8 mm in thickness, and /or echogenic pads between muscle groups of the rotator cuff
- 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...
- Biopsy of any tissue, showing Congo-red positive amyloid fibrils, and one diagnosis or surgical history of criterion 3- (1) to (5)
- Patient who meets any of the following 1 to 7 will be excluded from the study.
- Patient diagnosed with rheumatoid arthritis
- Patient diagnosed with osteoporosis
- Patient diagnosed with osteoarthritis
- Patient planning to receive renal transplantation during the study
- Patient for whom adequate anticoagulation cannot be achieved
- 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...
- Patient planning to become pregnant, pregnant, or breast-feeding
- Patient unable to understand or answer the questionnaires even with a proper assistance
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.