UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010214 |
|---|---|
| Receipt number | R000011529 |
| Scientific Title | Implication of central blood pressure and renal arterio-arteriolosclerosis in chronic kidney disease (CKD) patients |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2015/06/29 09:09:44 |
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Basic information
Public title
Implication of central blood pressure and renal arterio-arteriolosclerosis in chronic kidney disease (CKD) patients
Acronym
Central blood pressure and renal arterio-arteriolosclerosis
Scientific Title
Implication of central blood pressure and renal arterio-arteriolosclerosis in chronic kidney disease (CKD) patients
Scientific Title:Acronym
Central blood pressure and renal arterio-arteriolosclerosis
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relation between central blood pressure and renal arterio-arteriolosclerosis in CKD patients using the kidney tissues obtained by the renal biopsy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation between central systolic blood pressure and renal arterio-arteriolosclerosis
Key secondary outcomes
Relation between central systolic blood pressure and clinical indexes below
1) Renal histopathologic indexes (glomerulosclerosis, interstitial fibrosis/tubular atrophy, interstitial cell infiltration)
2) Cardio-ankle vascular index (CAVI)
3) Resistive index (RI) using the kidney doppler ultrasonography
4) Urinary parameters (albumin, N-acetyl-beta-glucosaminidase, beta2-microgloburin)
5) Renal function (estimated glomerular rate by creatinine and cystatin C)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement of central blood pressure
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) CKD patients who are planning to receive the renal biopsy
2) Patients with the informed consent to this study
Key exclusion criteria
1) Acute renal failure
2) Acute glomerulonephritis or rapidly progressive glomerulonephritis
3) Patients with inflammatory or consumptive diseases (e.g. infection, malignant tumor, vasculitis, collagen disease)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Komai |
Organization
Kawasaki Medical School
Division name
Department of Nephrology and Hypertension
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192
TEL
086-462-1111
komai@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tamehachi Namikoshi |
Organization
Kawasaki Medical School
Division name
Department of Nephrology and Hypertension
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192
TEL
086-462-1111
Homepage URL
tnamikoshi@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Nephrology and Hypertension, Kawasaki Medical School
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
| 2013 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/doi/10.1111/nep.12483/abstract
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
| 2013 | Year | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 12 | Day |
Last modified on
| 2015 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011529
