UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018523 |
|---|---|
| Receipt number | R000021440 |
| Scientific Title | Longitudinal observatinal study on patients receiving maintenance hemodialysis for more than 10 years: Impact of the onset of dialysis-related amyloidosis on QOL |
| Date of disclosure of the study information | 2015/08/03 |
| Last modified on | 2019/08/09 07:41:17 |
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Basic information
Public title
Longitudinal observatinal study on patients receiving maintenance hemodialysis for more than 10 years: Impact of the onset of dialysis-related amyloidosis on QOL
Acronym
Impact of the onset of dialysis-related amyloidosis on QOL in patients on hemodialysis for more than 10 years
Scientific Title
Longitudinal observatinal study on patients receiving maintenance hemodialysis for more than 10 years: Impact of the onset of dialysis-related amyloidosis on QOL
Scientific Title:Acronym
Impact of the onset of dialysis-related amyloidosis on QOL in patients on hemodialysis for more than 10 years
Region
| Japan |
Condition
Condition
Chronic kidney disease Stage 5D requiring maintenance hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the impact of dialysis-related amyloidosis on QOL in patients on hemodialysis for more than 10 years using a longitudinal observational study
Basic objectives2
Others
Basic objectives -Others
Actual condition survey
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
QOL changes during the two years evaluated by the EuroQOL (EQ-5D)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients on hemodialysis for more than 10 years
2. Patients whose age at informed consent is not less than 20 years
3. Patients with written informed consent
Key exclusion criteria
1. Patients who were re-initiated on hemodialysis after kidney transplantation
2. Patients who have no ability to respond to the questionnaire (EQ-5D)
3. Patients who are not considered to be appropriate to participate in this study
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Hirakata |
Organization
Fukuoka Renal Clinic
Division name
Division of Nephrology
Zip code
Address
4-6-20 Watanabe-dori, Chuo-ku, Fukuoka 810-0004, Japan
TEL
092-761-4937
hirakata@fukuoka-renal-clinic.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Otsuka |
Organization
Clinical Investigational Center
Division name
Kyushu Dialysis-Related Amyloidosis Study Group secretariat
Zip code
Address
3-11-4 Narusegaoka, Machida-shi, Tokyo 194-0011, Japan
TEL
042-810-2229
Homepage URL
otsuka@npo-cic.jp
Sponsor or person
Institute
Kyushu Dialysis-Related Amyloidosis Study Group
Institute
Department
Personal name
Funding Source
Organization
KANEKA Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 08 | Month | 03 | 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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study to evaluate the decline in QOL due to onset of DRA.
Management information
Registered date
| 2015 | Year | 08 | Month | 03 | Day |
Last modified on
| 2019 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021440
