UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031418 |
|---|---|
| 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 | 2025/02/27 09:36:11 |
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Basic information
Public title
A single arm, Multicenter study evaluating efficacy of beta 2-microglobulin adsorption column on dialysis-related amyloidosis
Acronym
A single arm, Multicenter study evaluating efficacy of beta 2-microglobulin adsorption column on dialysis-related amyloidosis
Scientific Title
A single arm, Multicenter study evaluating efficacy of beta 2-microglobulin adsorption column on dialysis-related amyloidosis
Scientific Title:Acronym
A single arm, Multicenter study evaluating efficacy of beta 2-microglobulin adsorption column on dialysis-related amyloidosis
Region
| Japan |
Condition
Condition
End-stage renal disease, Dialysis-related amyloidosis
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is a single, multinational study to evaluating efficacy of beta 2-microglobulin adsorption column on dialysis-related amyloidosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
Key secondary outcomes
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)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of beta 2-microglobulin adsorption column on dialysis-related amyloidosis. Every 3 times per week, for 12 months
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University School of Medicine
Division name
Urology
Zip code
0368164
Address
5 Zaifu-chou, Hirosaki, Japan
TEL
0172-39-5091
shingoh@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University School of Medicine
Division name
Urology
Zip code
0368164
Address
5 Zaifu-chou, Hirosaki, Japan
TEL
0172-39-5091
Homepage URL
shingoh@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kaneka Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
General Clinical Research Review Committee
Address
5 Zaifu-cho, Hirosaki-shi, Aomori
Tel
0172395091
shingoh@hirosaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
12
Results
Based on the preliminary eligibility survey, the planned number of participants was set at 12, but one person refused to participate, so the study began with 11 participants. Of the 11 participants, 9 completed the treatment as specified in the protocol, and 2 discontinued early in the study. The results of the 9 participants who completed the 1-year treatment were analyzed. There were no significant changes before and after treatment for the primary or secondary endpoints.
Results date posted
| 2025 | Year | 02 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study was conducted as a single-arm, prospective, interventional study as a specific clinical trial (jRCTs022200006). Patients with hemodialysis who met the diagnostic criteria for dialysis amyloidosis were treated with Rixell (S-15, S-25, or S-35) three times a week for one year. The primary endpoints were changes in the geriatric nutritional risk index (GNRI) and high-sensitivity CRP before and after treatment, and the secondary endpoints were changes in pre-dialysis b2MG concentration, prealbumin, leptin, carnitine, amino acid (3-methylhistidine), IL-6, joint pain (VAS evaluation), pinch strength (pinch meter), and frailty evaluation (Timed up and go test) before and after treatment.
Participant flow
The number of participants scheduled to be enrolled was set at 12 based on the preliminary eligibility survey, but one person refused to participate, so the study began with 11 participants. Of the 11 participants, 9 completed the treatment as specified in the protocol, and 2 discontinued early in the study. The reasons for discontinuation were grade 1 and grade 2 adverse events due to other diseases that were not causally related. The results of the 9 participants who completed the 1-year treatment were analyzed. There were no significant changes before and after treatment for either the primary or secondary endpoints.
Adverse events
The number of participants scheduled to be enrolled was set at 12 based on the preliminary eligibility survey, but one person refused to participate, so the study began with 11 participants. Of the 11 participants, 9 completed the treatment as specified in the protocol, and 2 discontinued early in the study. The reasons for discontinuation were grade 1 and grade 2 adverse events due to other diseases that were not causally related. The results of the 9 participants who completed the 1-year treatment were analyzed. There were no significant changes before and after treatment for either the primary or secondary endpoints.
Outcome measures
The primary endpoints were changes in the geriatric nutritional risk index (GNRI) and high-sensitivity CRP before and after treatment, and the secondary endpoints were changes in pre-dialysis b2MG concentration, prealbumin, leptin, carnitine, amino acid (3-methylhistidine), IL-6, joint pain (VAS evaluation), pinch strength (pinch meter), and frailty evaluation (Timed up and go test) before and after treatment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 22 | Day |
Last modified on
| 2025 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035878
