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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004733
Receipt No. 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

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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
Email 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
Email betamacl25@yahoo.co.jp

Sponsor
Institute beta2-microgloblin removal therapy study group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005637

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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