Unique ID issued by UMIN | UMIN000031418 |
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Receipt number | R000035878 |
Scientific Title | A single arm, Multicenter study evaluating efficacy of beta 2-microglobulin adsorption column on dialysis-related amyloidosis |
Date of disclosure of the study information | 2018/05/01 |
Last modified on | 2018/04/22 07:45:53 |
A single arm, Multicenter study evaluating efficacy of beta 2-microglobulin adsorption column on dialysis-related amyloidosis
A single arm, Multicenter study evaluating efficacy of beta 2-microglobulin adsorption column on dialysis-related amyloidosis
A single arm, Multicenter study evaluating efficacy of beta 2-microglobulin adsorption column on dialysis-related amyloidosis
A single arm, Multicenter study evaluating efficacy of beta 2-microglobulin adsorption column on dialysis-related amyloidosis
Japan |
End-stage renal disease, Dialysis-related amyloidosis
Nephrology | Urology |
Others
NO
This is a single, multinational study to evaluating efficacy of beta 2-microglobulin adsorption column on dialysis-related amyloidosis
Efficacy
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
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)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Use of beta 2-microglobulin adsorption column on dialysis-related amyloidosis. Every 3 times per week, for 12 months
20 | years-old | <= |
100 | years-old | >= |
Male and Female
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.
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.
30
1st name | |
Middle name | |
Last name | Shingo Hatakeyama |
Hirosaki University School of Medicine
Urology
5 Zaifu-chou, Hirosaki, Japan
0172-39-5091
shingoh@hirosaki-u.ac.jp
1st name | |
Middle name | |
Last name | Shingo Hatakeyama |
Hirosaki University School of Medicine
Urology
5 Zaifu-chou, Hirosaki, Japan
0172-39-5091
shingoh@hirosaki-u.ac.jp
Hirosaki University School of Medicine
Kaneka Co.
Profit organization
Japan
NO
2018 | Year | 05 | Month | 01 | Day |
Unpublished
Preinitiation
2018 | Year | 02 | Month | 21 | Day |
2018 | Year | 05 | Month | 01 | Day |
2018 | Year | 02 | Month | 22 | Day |
2018 | Year | 04 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035878
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