UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020417 |
|---|---|
| Receipt number | R000023580 |
| Scientific Title | A observational study evaluating impact of big toenail opacity on prognosis in hemodialysis patients with end-stage renal disease |
| Date of disclosure of the study information | 2016/01/04 |
| Last modified on | 2018/12/29 09:19:01 |
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Basic information
Public title
A observational study evaluating impact of big toenail opacity on prognosis in hemodialysis patients with end-stage renal disease
Acronym
A observational study evaluating impact of big toenail opacity on prognosis in hemodialysis patients
Scientific Title
A observational study evaluating impact of big toenail opacity on prognosis in hemodialysis patients with end-stage renal disease
Scientific Title:Acronym
A observational study evaluating impact of big toenail opacity on prognosis in hemodialysis patients
Region
| Japan |
Condition
Condition
hemodialysis patients with end-stage renal disease
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is a prospective observational cohort study to investigate whether nail disorders (big toenail opacity) predict prognosis of hemodialysis patients.
Basic objectives2
Others
Basic objectives -Others
survival
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
lower limb survival (foot ulceration or amputation events)
Identification of risk factors for lower limb events and overall survival
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were 1) Males, 20 years or older, and 2) patients with end-stage renal disease on hemodialysis who agreed to enter the present study.
In this study, poor general health, major concomitant disease (e.g., terminal cancer), or other medical condition likely to result in death within 6 months after the time of toenail investigation were not in exclusion criteria.
Key exclusion criteria
Exclusion criteria were 1) hemodialysis patients without both lower limbs, or 2) refused to enter the present study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Hatakeyama |
Organization
Hirosaki University Graduate School of Medicine
Division name
Urology
Zip code
Address
5 Zaifu-chou, Hirosaki, Japan
TEL
+81172395091
shingorilla2@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Hatakeyama |
Organization
Hirosaki University Graduate School of Medicine
Division name
Urology
Zip code
Address
5 Zaifu-chou, Hirosaki, Japan
TEL
+81172395091
Homepage URL
shingorilla2@gmail.com
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
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
| 2016 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 01 | Day |
Other
Other related information
Observational cohort study
Hemodialysis patients who received hemodialysis at Oyokyo Kidney Research Institute from September 2010 to December 2015. Nail disorders were evaluated by opacity ratio of big toenail. Patients were allocated into two groups: presence or absence of big toenail disorders. The primary endpoint was overall survival. The secondary endpoints were lower limb survival (foot ulceration or amputation events), and risk factors for lower limb events and overall survival. Risk factors included patient demographics, comorbidities, blood test, and presence of toenail opacity. Overall and lower limb survivals were evaluated using Kaplan-Meier methods with log-lank test between two groups. Multivariate Cox regression analyses were performed to assess predictors for poor prognostic factors.
Management information
Registered date
| 2016 | Year | 01 | Month | 02 | Day |
Last modified on
| 2018 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023580
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
