UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018431 |
|---|---|
| Receipt number | R000021341 |
| Scientific Title | Retrospective study of Erythropoiesis STimulating Agent dose ReducTion on hemodialysis patients by using anti-thrombogenic membrane |
| Date of disclosure of the study information | 2015/08/31 |
| Last modified on | 2018/09/26 00:17:17 |
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Basic information
Public title
Retrospective study of Erythropoiesis STimulating Agent dose ReducTion on hemodialysis patients by using anti-thrombogenic membrane
Acronym
RESTART Study
Scientific Title
Retrospective study of Erythropoiesis STimulating Agent dose ReducTion on hemodialysis patients by using anti-thrombogenic membrane
Scientific Title:Acronym
RESTART Study
Region
| Japan |
Condition
Condition
Chronic renal disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is examined whether switching to anti-thrombogenic dialyzer affects the responsibility to ESA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Responsibility for erythropoiesis stimulating agent 6 or 12 months after the beginning of observation.
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) Outpatients who had been treated with more than 4h dialysis three times a week.
2) Patients who had been treated more than 3 months with polysulfone type dialyzers excluding NV, (their dialysis vintages are more than 3 months).
3) Patients who had been more than 20 years old.
4) Patients to whom erythropoiesis stimulating agent had been prescribed
Key exclusion criteria
For 3 months before the beginning of observation and during observation period, patients who had fulfilled conditions below were excluded.
1) Patients who had been treated with other renal insufficiency therapies, continuous ambulatory peritoneal dialysis and hemodiafiltration, excluding hemodialysis.
2) Patients to whom Epoetin Beta Pegol (CERA) had been prescribed.
3) Patients to whom blood transfusion had been conducted.
4) Patients who had been hospitalized for more than 2 weeks.
5) Patients who had become pregnant or given birth.
6) Patients who had hematologic diseases excluding renal anemia.
7) Patients who had been treated for a malignant tumor.
8) Patients who is judged as the inadequate subject of this study by the doctor.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takatoshi Kakuta |
Organization
Tokai University Hachioji Hospital
Division name
ivision of Nephrology, Endocrinology and Metabolism
Zip code
Address
1838 Ishikawa-nachi, Hachioji-shi, Tokyo
TEL
042-639-1111
kakuta@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takatoshi Kakuta |
Organization
Tokai University Hachioji Hospital
Division name
ivision of Nephrology, Endocrinology and Metabolism
Zip code
Address
1838 Ishikawa-nachi, Hachioji-shi, Tokyo
TEL
042-639-1111
Homepage URL
kakuta@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
RESTART Study group
Institute
Department
Personal name
Funding Source
Organization
TORAY Industries Inc.
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 | 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
| 2015 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 09 | Month | 01 | Day |
Other
Other related information
In previous prospective clinical study, TORAYLIGHT NV had a possibility to reduce erythropoiesis stimulating agent.
Management information
Registered date
| 2015 | Year | 07 | Month | 27 | Day |
Last modified on
| 2018 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021341
| 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 |
