UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004733 |
|---|---|
| Receipt number | R000005637 |
| Scientific Title | Prospective cohort study on dialysis associated spondylosis(DAS) of dialysis related amyloidosis(DRA) patients in Japan (PCDJ) |
| Date of disclosure of the study information | 2010/12/16 |
| Last modified on | 2017/06/21 14:09:34 |
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Basic information
Public title
Prospective cohort study on dialysis associated spondylosis(DAS) of dialysis related amyloidosis(DRA) patients in Japan (PCDJ)
Acronym
Prospective cohort study on DAS of DRA patients in Japan (PCDJ)
Scientific Title
Prospective cohort study on dialysis associated spondylosis(DAS) of dialysis related amyloidosis(DRA) patients in Japan (PCDJ)
Scientific Title:Acronym
Prospective cohort study on DAS of DRA patients in Japan (PCDJ)
Region
| Japan |
Condition
Condition
Dialysis related amyloidosis
Classification by specialty
| Nephrology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will make the database of DRA to reveal the risk factors and the progress of DRA by prospective surveillance of radiographic imaging of cervical spine and lumbar spine in patients with DRA, including patient background, treatment protocol and so on.
Basic objectives2
Others
Basic objectives -Others
Observational
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)change in intervertebral height of cervical spine and lumbar spine
(2)change in clinical entity [stage and form] of DSA according to the method described by Maruo et al.
Key secondary outcomes
Base
Study type
Observational
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who correspond to all the following conditions
(1)Patients who have a medical history of carpal tunnel surgery or trigger finger surgery.
(2)Patients who have been undergoing hemodialysis for ten years or more.
(3)Patients who are diagnosed as suspected cases or definite cases for the tentative criteria of DRA described in the report of the research and surveillance group for amyloidosis in 2009 (Scientific Research Grant of MHLW, The Project for Conquering Refractory Diseases).
Key exclusion criteria
(1)Patients who have a medical history of surgery for diseases in cervical spine of lumbar spine
(2)Patients who are complicated by Rheumatoid arthritis
(3)Patients who were considrered as ineligible for this trial by the attending doctor
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Nakanishi |
Organization
Hyogo College of Medicine
Division name
Department of Internal Medicne, Division of Kidney and Dialysis
Zip code
Address
1-1 Mukogawa-cho Nishinomiya, Hyogo
TEL
0798-45-6521
kuragano@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Kuragano |
Organization
Hyogo College of Medicine
Division name
Department of Internal Medicne, Division of Kidney and Dialysis
Zip code
Address
1-1 Mukogawa-cho Nishinomiya, Hyogo
TEL
0798-45-6521
Homepage URL
betamacl25@yahoo.co.jp
Sponsor or person
Institute
beta2-microgloblin removal therapy study group
Institute
Department
Personal name
Funding Source
Organization
beta2-microgloblin removal therapy study group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 12 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective cohort study
Management information
Registered date
| 2010 | Year | 12 | Month | 16 | Day |
Last modified on
| 2017 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005637
