UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038457
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ytakemoto@msic.med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043823

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.