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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031418
Receipt No. 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

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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
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University School of Medicine
Division name Urology
Zip code
Address 5 Zaifu-chou, Hirosaki, Japan
TEL 0172-39-5091
Email shingoh@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University School of Medicine
Division name Urology
Zip code
Address 5 Zaifu-chou, Hirosaki, Japan
TEL 0172-39-5091
Homepage URL
Email shingoh@hirosaki-u.ac.jp

Sponsor
Institute Hirosaki University School of Medicine
Institute
Department

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
Address
Tel
Email

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 02 Month 21 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
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
2018 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035878

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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