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NCT02952144 · ClinicalTrials.gov registry record · NA
Post Approval Study of Lixelle for the Treament of Dialysis-Related Amyloidosis
A NA study of Dialysis Amyloidosis, sponsored by Kaneka Medical America.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT02952144 is a NA study of Dialysis Amyloidosis that is actively recruiting participants, run by Kaneka Medical America. The registered enrollment target is 40 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02952144, a NA study of Dialysis Amyloidosis, is actively recruiting participants, sponsored by Kaneka Medical America.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
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 Studied
Interventions
- DEVICE Lixelle® treatment
Study Locations (1)
New York
- The Rogosin Institute - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-10 |
| Est. Completion | 2026-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02952144
The ClinicalTrials.gov registry entry for NCT02952144 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaneka Medical America, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Dialysis Amyloidosis appearing as the primary indexed condition, and to 1 intervention - of which Lixelle® treatment is the first listed.
NCT02952144 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT02952144 about?
NCT02952144 is a clinical study titled "Post Approval Study of Lixelle for the Treament of Dialysis-Related Amyloidosis". 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 patien...
What is the current status of trial NCT02952144?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2015-10. Estimated completion is 2026-12.
What conditions does trial NCT02952144 study?
This clinical trial studies the following conditions: Dialysis Amyloidosis.
What interventions are being tested in trial NCT02952144?
The interventions under investigation include: Lixelle® treatment (DEVICE).
Who is sponsoring clinical trial NCT02952144?
This trial is sponsored by Kaneka Medical America, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02952144 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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