UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective cohort study on dialysis associated spondylosis(DAS) of dialysis related amyloidosis(DRA) patients in Japan (PCDJ)
Title of the study (Brief title)	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	Takeshi Nakanishi
Organization	Hyogo College of Medicine
Division name	Department of Internal Medicne, Division of Kidney and Dialysis
Address	1-1 Mukogawa-cho Nishinomiya, Hyogo
TEL	0798-45-6521
Email	kuragano@hyo-med.ac.jp

Public contact
Name of contact person	Takahiro Kuragano
Organization	Hyogo College of Medicine
Division name	Department of Internal Medicne, Division of Kidney and Dialysis
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 11 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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