UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004905 |
|---|---|
| Receipt number | 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 12:09:27 |
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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
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
sofue@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University, Faculty of Medicine
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005838
