UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025728 |
|---|---|
| Receipt number | R000029599 |
| Scientific Title | Effect of different high performance membrane dualyzers on survival in chronic hemodialysis patients |
| Date of disclosure of the study information | 2018/12/31 |
| Last modified on | 2017/01/18 14:18:41 |
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Basic information
Public title
Effect of different high performance membrane dualyzers on survival in chronic hemodialysis patients
Acronym
Dialyzers on HD patients
Scientific Title
Effect of different high performance membrane dualyzers on survival in chronic hemodialysis patients
Scientific Title:Acronym
Dialyzers on HD patients
Region
| Japan |
Condition
Condition
Ptients on hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the association between different dialyzer membranes and mortality rates in patients on hemodialysis
Basic objectives2
Others
Basic objectives -Others
To estimate the predictors for mortality in patients on dialysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
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
1)Patients who had received maintenance dialysis between December 2008 and December 20012. 2)Patients who were received maintenance hemodialysis thrice a week, who had received maintenance dialysis for at least 2 years at the end of the year 2008, 3)and who were treated with seven major dialyzers, namely, cellulose triacetate (CTA), ethylene vinyl alcohol (EVAL), polyacrylonitrile (PAN), polyester polymer alloy (PEPA), polyethersulfone (PES), polymethylmethacrylate (PMMA), and polysulfone (PS) membranes.
Key exclusion criteria
Patients who had been dialyzed fewer than three times a week or fewer than two hours per treatment, who had treated with other than above mentioned major 7 dialyzers, those who had received peritoneal dialysis, those with a history of organ transplantation, age < 18 years old, and those whose records covering date of birth, dialysis initiation, or outcome were incomplete.
Target sample size
140000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Abe |
Organization
Japanese Society for Dialysis Therapy
Division name
The Committee of Renal Data Registry
Zip code
Address
2-38-21, Hongo, Bunkyou-ku, Tokyo, Japan
TEL
03-5800-0786
abe.masanori@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Abe |
Organization
Nihon University School of Medicine
Division name
Nephrology, Hypertension and Endocrinology
Zip code
Address
30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo, 173-8610, Japan
TEL
03-3972-8111
Homepage URL
abe.masanori@nihon-u.ac.jp
Sponsor or person
Institute
Japanese Society for Dialysis Therapy
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2018 | Year | 12 | Month | 31 | 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
| 2016 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The data were obtained from the annual nationwide surveys of dialysis patients which is Japanese Renal Data Registry (JRDR) system conducted by the Japanese Society for Dialysis Therapy (JSDT). The surveys were conducted by JSDT volunteers, with details described previously. Briefly, data covered 282,622 patients receiving hemodialysis at 4,072 facilities in the 2008 survey, and 290,675 patients at 4,125 facilities in the 2009 survey. The study population consisted of patients who had received maintenance dialysis between December 2008 and December 2012.
Management information
Registered date
| 2017 | Year | 01 | Month | 18 | Day |
Last modified on
| 2017 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029599
| 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 |
