UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056222 |
|---|---|
| Receipt number | R000064234 |
| Scientific Title | Association Between Home Hemodialysis skills Assessment and Treatment Survival. |
| Date of disclosure of the study information | 2024/11/21 |
| Last modified on | 2024/11/21 08:43:02 |
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Basic information
Public title
Association Between Home Hemodialysis skills Assessment and Treatment Survival.
Acronym
Association Between Home Hemodialysis skills Assessment and Treatment Survival.
Scientific Title
Association Between Home Hemodialysis skills Assessment and Treatment Survival.
Scientific Title:Acronym
Association Between Home Hemodialysis skills Assessment and Treatment Survival.
Region
| Japan |
Condition
Condition
End stage kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to elucidate the relationship between the Home Hemodialysis Skill Assessment (HHSA) score and treatment continuation rate in patients undergoing Home Hemodialysis (HHD).
Basic objectives2
Others
Basic objectives -Others
The objective is to elucidate the technique survival rate and overall survival rate in patients undergoing home hemodialysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technique failure (defined as discontinuation of home hemodialysis therapy for more than 60 days for reasons other than death, transfer or transplantation,) and mortality.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All home hemodialysis patients at Saitama Medical University Hospital who underwent home hemodialysis technique assessment between January 1, 2015, and December 31, 2016.
Key exclusion criteria
Exclude missing data and early withdrawals within 3 months
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Okada |
Organization
Saitama medical university hospital
Division name
Nephrology
Zip code
3500495
Address
38 Morohongo, Moroyama-cho, Iruma-gun, Saitama Prefecture
TEL
0492761611
tomori.koji@1972.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Tomori |
Organization
Saitama medical university hospital
Division name
Nephrology
Zip code
3500495
Address
38 Morohongo, Moroyama-cho, Iruma-gun, Saitama Prefecture
TEL
0492761611
Homepage URL
tomori.koji@1972.saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical university hospital
Institute
Department
Personal name
Funding Source
Organization
Saitma medical university hospital
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
Saitama medical university hospital
Address
38 Morohongo, Moroyama-cho, Iruma-gun, Saitama Prefecture
Tel
0492761111
hirb@saitama-med.ac.jp
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
| 2024 | Year | 11 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This observational study aims to elucidate the association between home hemodialysis technique assessment and treatment continuation rates.
Management information
Registered date
| 2024 | Year | 11 | Month | 21 | Day |
Last modified on
| 2024 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064234
