UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000411 |
|---|---|
| Receipt number | 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 09:58:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kuragano@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College 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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000429
