A single arm, Multicenter study evaluating efficacy of beta 2-microglobulin adsorption column on dialysis-related amyloidosis

Not Applicable

• Conditions: End-stage renal disease, Dialysis-related amyloidosis

• Registration Number: JPRN-UMIN000031418
• Lead Sponsor: Hirosaki University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Clinical evidence of any active cancer at Visit 1. Clinical evidence of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study. History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1. Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1. History of drug, alcohol, or substance abuse within the 6 months before Visit 1. Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to beta 2-microglobulin adsorption column.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline to 1 year in geriatric nutritional risk index [GNRI=(14.89*serum albumin(g/dL)+41.7*(body weight(kg)/standard weight(kg)] and high-sensitive C-reactive protein

Secondary Outcome Measures

Name	Time	Method
Change from Baseline to 1 year in Beta 2-microglobulin level, prealbumin, leptin, carnitine, 3-methyl histidine, Interleuikn-6, Joint pain (measured by VAS), pinch strength, frailty (Timed up and go test)