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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000001589
Receipt No. R000001830
Scientific Title Observational Study on Cerebro- and Cardio-vascular Complication in Predialysis, Hemodialysis, and Peritoneal Dialysis Patients with Chronic Kidney Disease
Date of disclosure of the study information 2008/12/19
Last modified on 2013/12/25

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Basic information
Public title Observational Study on Cerebro- and Cardio-vascular Complication in Predialysis, Hemodialysis, and Peritoneal Dialysis Patients with Chronic Kidney Disease
Acronym VCOHP Study
Scientific Title Observational Study on Cerebro- and Cardio-vascular Complication in Predialysis, Hemodialysis, and Peritoneal Dialysis Patients with Chronic Kidney Disease
Scientific Title:Acronym VCOHP Study
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Medicine in general Cardiology Nephrology
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the degree of progression of cerebro- and cardio-vascular complication in predialysis, hemodialysis, and peritoneal dialysis patients with chronic kidney disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Alteration of brain volume in MRI
2. Alteration of calcification score in coronary CT
Key secondary outcomes 1. Incidence rate of overt cerebro- and cardio-vascular complications
2. Intima-media thickness of common carotid artery
3. Cardiac function examined by echocardiography and cine-MRI
4. Pulse wave velocity examined by MRI
5. Augmentation Index (AI)
6. Bone mineral density examined by dual-energy X-ray absorptiometry
7. Residual renal function
8. Higher brain function quantified using Japan Stroke Scale Higher Cortical Function (JSS-H)
9. Quality of life quantified using the Kidney Disease Quality of Life Short Form (KDQOL-SF)

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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Predialysis patients with chronic kidney disease
2. Patients with end-stage renal disease on either hemodialysis or peritoneal dialysis, who started dialysis within 2 years of study entry
Key exclusion criteria 1. Pregnant women, or women who have a possibility of pregnancy
2. Patients using acidic dialysate
3. Patients who have previously received another dialysis therapy for over 3 months
4. Patients who have previously undergone renal transplantation
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Tsuruya
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Integrated Therapy for Chronic Kidney Disease
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL 092-642-5843
Email tsuruya@intmed2.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisako Yoshida
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Integrated Therapy for Chronic Kidney Disease
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582
TEL 092-642-5843
Homepage URL
Email hisako@kcu.med.kyushu-u.ac.jp

Sponsor
Institute Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University
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
2008 Year 12 Month 19 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 Enrolling by invitation
Date of protocol fixation
2008 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2008 Year 12 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 Predialysis chronic kidney disease patients and patients with end-stage renal disease on hemodialysis (HD) and peritoneal dialysis (PD) whose dialysis duration is within 2 years are recruited and registered. All patients undergo brain MRI, chest CT, echocardiography, cine-MRI, carotid artery echo, pulse wave velocity examination, and dual-energy X-ray absorptiometry, and are examined higher brain function using Japan Stroke Scale Higher Cortical Function (JSS-H) and quality of life using the Kidney Disease Quality of Life Short Form (KDQOL-SF) at the entry and 2 years later. The changes of these parameters during 2 years are compared among predialysis, HD and PD patients.

Management information
Registered date
2008 Year 12 Month 18 Day
Last modified on
2013 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001830

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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