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

Recruiting N/A Interventional Study
Dialysis Amyloidosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Kaneka Medical America LLC · Industry
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About This Trial
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 bl…
Trial Locations
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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 rot…
Contacts

Joanne McLaughlin

(646) 202-3566

joanne.mclaughlin@kaneka.com

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