Blood filter may clear the protein behind dialysis joint pain
NCT ID NCT02952144
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This trial tests a device called Lixelle, which attaches to a standard dialysis machine to filter out beta-2 microglobulin, a protein that builds up in the blood of people on long-term dialysis and can cause painful joint and bone deposits. The study includes 40 adults on thrice-weekly hemodialysis who have been diagnosed with dialysis-related amyloidosis. Researchers will compare how often serious side effects occur in people using Lixelle versus those not using it, and whether the filter lowers blood protein levels and eases symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lixelle column, a device that filters blood during dialysis to remove beta-2 microglobulin
- What this could lead to
- If it works, this could offer a way to ease joint pain and improve daily function for people on long-term dialysis who develop amyloidosis.
- What could go wrong
- This is a small, early-stage trial with 40 participants, so results may not apply to everyone. The treatment requires longer dialysis sessions and may not reduce symptoms for all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2015
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Rogosin Institute
New York, New York, 10021, United States