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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000411
Receipt No. R000000429
Scientific Title Prospective study for Analysing the Significant factors Affecting Prognosis and cardiovascular disease in chronic kidney disease
Date of disclosure of the study information 2006/05/01
Last modified on 2016/08/20

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Basic information
Public title Prospective study for Analysing the Significant factors Affecting Prognosis and cardiovascular disease in chronic kidney disease
Acronym ASAP study
Scientific Title Prospective study for Analysing the Significant factors Affecting Prognosis and cardiovascular disease in chronic kidney disease
Scientific Title:Acronym ASAP study
Region
Japan

Condition
Condition Patients with chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Determinig the significant factors affecting the prognosis and cardiovascular event in patients with chronic kidney disease.
Basic objectives2 Others
Basic objectives -Others Analyzing the relationships among oxidative stress, iron metabolism, inflammation,nutritional state and endothelial function in patients with chronic kidney disease.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Mortality. Morbidity. Hospitalization.
Key secondary outcomes Endothelial function. Oxidative stress.
Index of atherosclerosis. Chronic inflammation.
Residual renal function.
Classical risk factors of atherosclerosis. Nutritional state.

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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients with chronic kidney disease
Key exclusion criteria Patients with malignancy, infection and severe liver and lung disease
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Kuragano
Organization Hyogo College of Medicine
Division name Department of internal medicine, Division of kidney and dialysis
Zip code
Address 1-1 Mukogawa cho, Nishinomiya, Japan
TEL 0798-45-6521
Email kuragano@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Kuragano
Organization Hyogo College of Medicine
Division name Department of internal medicine, Division of kidney and dialysis
Zip code
Address 1-1 Mukogawa cho, Nishinomiya, Japan
TEL 0798-45-6521
Homepage URL
Email kuragano@hyo-med.ac.jp

Sponsor
Institute Hyogo College 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
2006 Year 05 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 Completed
Date of protocol fixation
2005 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 05 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A prospective clinical study

Management information
Registered date
2006 Year 04 Month 27 Day
Last modified on
2016 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000429

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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