UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037093 |
|---|---|
| Receipt number | R000042267 |
| Scientific Title | Structural analysis of beta2-microglobulin-related amyloid fibrils purified from human tissues. |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2019/06/18 14:37:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Structural analysis of beta2-microglobulin-related amyloid fibrils purified from human tissues.
Acronym
Structural analysis of beta2-microglobulin-related amyloid fibrils purified from human tissues.
Scientific Title
Structural analysis of beta2-microglobulin-related amyloid fibrils purified from human tissues.
Scientific Title:Acronym
Structural analysis of beta2-microglobulin-related amyloid fibrils purified from human tissues.
Region
| Japan |
Condition
Condition
Dialysis-related amyloidosis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand molecular interaction in beta2-microglobulin-related amyloid fibrils purified from human tissues.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Structural analysis with NMR and Cryo-EM of beta2-microglobulin-related amyloid fibrils purified from human tissues.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Dialysis patients who had surgery for dialysis-related amyloidosis.
Key exclusion criteria
Patients without dialysis-related amyloidosis
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Blood Purification Therapy
Zip code
9518520
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata, Japan
TEL
0252272200
yamamots@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Suguru |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Blood Purification Therapy
Zip code
9518520
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata, Japan
TEL
0252272200
Homepage URL
yamamots@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Institute for Protein Research, Osaka University and Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University
Address
1-754 Asahimachi-dori, Niigata 951-8510
Tel
0252272625
ethics@adm.niigata-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
新潟大学医歯学総合病院,
大阪大学 蛋白質研究所
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A cross sectional study
Management information
Registered date
| 2019 | Year | 06 | Month | 17 | Day |
Last modified on
| 2019 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042267
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
