End-stage renal disease, Dialysis-related amyloidosis
Conditions
Interventions
Use of beta 2-microglobulin adsorption column on dialysis-related amyloidosis. Every 3 times per week, for 12 months
Sponsors
Hirosaki University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with end-stage renal disease, 20 years or older, with dialysis-related amyloidosis Agree to use beta 2-microglobulin adsorption column Have not used beta 2-microglobulin adsorption column.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactShingo Hatakeyama
Hirosaki University School of Medicine Urology
Outcome results
None listed