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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004905
Receipt No. R000005838
Scientific Title An exploratory investigation of the biomarker for senescence and arteriosclerosis in renal transplant donors and recipients.
Date of disclosure of the study information 2011/01/24
Last modified on 2014/07/26

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Basic information
Public title An exploratory investigation of the biomarker for senescence and arteriosclerosis in renal transplant donors and recipients.
Acronym An exploratory investigation of the biomarker for senescence and arteriosclerosis in renal transplant donors and recipients.
Scientific Title An exploratory investigation of the biomarker for senescence and arteriosclerosis in renal transplant donors and recipients.
Scientific Title:Acronym An exploratory investigation of the biomarker for senescence and arteriosclerosis in renal transplant donors and recipients.
Region
Japan

Condition
Condition Recipients and donors in living-kidney transplantation
Classification by specialty
Cardiology Nephrology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the biomarkers for subclinical senescence and arteriosclerosis in the donors` kidneys and to clarify the mechanism of the allograft senescence
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1)AGT (urine and serum),soluble (pro) renin receptor (urine and serum) and plasma AMDA: 0,12,36,60 months
2)Senescence-associated beta galactosidase and arteriosclerosis in donated kidney or allograft: 0,12,36,60 months
Key secondary outcomes 1)Cr and eGFR in donors and recipients: 0,6,12,24,36,48,60 months
2)CAVI and central BP: 0,12,36,60 months
3)urinary albumin, proteinuria and urinary occult blood: 0,6,12,24,36,48,60 months
4)patient survival rates, allograft survival rates and cardiovascular events: 0-60months
5)BP: 0,6,12,24,36,48,60 months

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
16 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who are scheduled living-kidney transplantation as recipients or donors in Kagawa University Hospital and agreed with the study
Key exclusion criteria 1)Kidney transplant from cadaver donors or brain-dead donors.
2)Patients who are under 16 years-old
3)Patients without agreement
4)Patients inadequate for the study
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Kohno
Organization Kagawa University, Faculty of Medicine
Division name Department of Cardiorenal and Cerebrovascular Medicine
Zip code
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL 087-891-2149
Email sofue@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadashi Sofue
Organization Kagawa University, Faculty of Medicine
Division name Department of Cardiorenal and Cerebrovascular Medicine
Zip code
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL 087-891-5111
Homepage URL
Email sofue@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa University, Faculty of Medicine
Institute
Department

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
Email

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
2011 Year 01 Month 24 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 Open public recruiting
Date of protocol fixation
2010 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective cohort study
Predictive variable: kidney senescence and several biomarkers
Outcome variable: eGFRs in donors and recipients

Management information
Registered date
2011 Year 01 Month 19 Day
Last modified on
2014 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005838

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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