UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038457 |
|---|---|
| Receipt number | R000043823 |
| Scientific Title | Study of the effects of AMG(alpha1-micoroglobulin) reduction rates on the survival, complications and prognosis in dialysis patients |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2019/10/31 23:31:30 |
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Basic information
Public title
Study of the effects of AMG(alpha1-micoroglobulin) reduction rates on the survival, complications and prognosis in dialysis patients
Acronym
JAMREDS Study
Scientific Title
Study of the effects of AMG(alpha1-micoroglobulin) reduction rates on the survival, complications and prognosis in dialysis patients
Scientific Title:Acronym
JAMREDS Study
Region
| Japan |
Condition
Condition
Chronic hemodialysis in out-patients
Classification by specialty
| Medicine in general | Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A prospective observational study of hemodialysis (HD, hemodiafiltration; HDF)patients revealed that the reduction rates of alpha1-microglobulin (AMG) was prognostic / cardiovascular(Cardiovascular disease; CVD) events will be examined from the following three viewpoints.
1) Effect of AMG reduction rates on survival outcome and CVD events.
2) Effects of each treatment modality of blood purification therapy (HD, intermittent infusion HDF (iHDF), pre-dilution online HDF, post-dilution online HDF) on survival and CVD events (considering AMG reduction rates replaced with treatment mode)
3) Effects of AMG reduction rates on survival and CVD events in patients undergoing HDF therapy (iHDF, predilution online HDF, postdilution online HDF)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival and cardiovasculardisease events
Key secondary outcomes
Survival or cardiovascular disease events
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stable hemodialysis out-patients. Patients who were more than 6 months post-dialysis initiation.
Key exclusion criteria
Patients with malignancy, clinically overt infection, acute or severe illness, dementia and dialysis re-initiation after functional loss of transplanted kidney.
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Takemoto |
Organization
Osaka City University
Division name
Urology
Zip code
545-8586
Address
1-4-3, asahi-machi, abeno-ku, Osaka, Osaka, Japan
TEL
06-6645-2393
ytakemoto@msic.med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Takemoto |
Organization
Osaka City University
Division name
Urology
Zip code
545-8586
Address
1-4-3, asahi-machi, abeno-ku, Osaka, Osaka, Japan
TEL
06-6645-2393
Homepage URL
ytakemoto@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Hemodiafiltration, Japanese Society of high perfoemance membrane for blood purification, Intermittent infusion HemoDiaFiltration
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Urology, Osaka City University
Address
1-4-3,asahi-machi,abeno-ku, Osaka, Osaka, Japan
Tel
06-6645-2393
ytakemoto@msic.med.osaka-cu.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
| 2019 | Year | 11 | Month | 01 | 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
| 2019 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective observational study of hemodialysis (HD, hemodiafiltration; HDF)patients revealed that the reduction rates of alpha1-microglobulin (AMG) was prognostic / cardiovascular(Cardiovascular disease; CVD) events will be examined from the following three viewpoints.
1) Effect of AMG reduction rates on survival outcome and CVD events.
2) Effects of each treatment modality of blood purification therapy (HD, intermittent infusion HDF (iHDF), pre-dilution online HDF, post-dilution online HDF) on survival and CVD events (considering AMG reduction rates replaced with treatment mode)
3) Effects of AMG reduction rates on survival and CVD events in patients undergoing HDF therapy (iHDF, predilution online HDF, postdilution online HDF)
Management information
Registered date
| 2019 | Year | 10 | Month | 31 | Day |
Last modified on
| 2019 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043823
