UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017519 |
|---|---|
| Receipt number | R000020304 |
| Scientific Title | Investigation of risk factors for mortality, cardiovascular events, and kidney disease progression in patients with chronic kidney disease: a observational study. |
| Date of disclosure of the study information | 2015/05/12 |
| Last modified on | 2019/05/16 16:21:35 |
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Basic information
Public title
Investigation of risk factors for mortality, cardiovascular events, and kidney disease progression in patients with chronic kidney disease: a observational study.
Acronym
Investigation of risk factors for mortality, cardiovascular events, and kidney disease progression in patients with chronic kidney disease: a observational study.
Scientific Title
Investigation of risk factors for mortality, cardiovascular events, and kidney disease progression in patients with chronic kidney disease: a observational study.
Scientific Title:Acronym
Investigation of risk factors for mortality, cardiovascular events, and kidney disease progression in patients with chronic kidney disease: a observational study.
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the risk factors for mortality, cardiovascular events, and kidney disease progression in patients with chronic kidney disease.
Basic objectives2
Others
Basic objectives -Others
All-cause and cardiovascular mortality and adverse renal outcomes(end-stage renal
disease requiring dialysis,doubling of serum creatinine,and eGFR slope).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of cardiovascular diseases and association of clinical parameters with cardiovascular diseases and subsequent cardiovascular diseases.
Key secondary outcomes
Association of clinical parameters with
all-cause and cardiovascular mortality, and adverse renal outcomes (doubling of serum creatinine, end-stage renal disease requiring dialysis and slope of estimated glomerular filtration rate).
Relationships among clinical
characteristics at baseline on a cross-sectional analysis.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who were admitted to our hospital for evaluation and education of chronic kidney disease since June 2009 and gave written-informed consent.
2) Additional patients who were admitted to our hospital for evaluation and education of chronic kidney disease between January 2005 and May 2009 and gave informed consent by disclosure of information.
Key exclusion criteria
1) Patient who did not give informed consent.
2) Patients under poor condition who were accompanied by acute phase of infectious, cardiovascular, respiratory, digestive system, and liver diseases.
3) Patients who were judged as inappropriate by attending physicians.
Target sample size
99999
Research contact person
Name of lead principal investigator
| 1st name | MASARU |
| Middle name | |
| Last name | NAKAYAMA |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Nephrology
Zip code
810-8563
Address
1-8-1 Jigyohama, Chuo-Ku,Fukuoka 810-8563,Japan
TEL
092-852-0700
nakayama.masaru.kv@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | MASARU |
| Middle name | |
| Last name | NAKAYAMA |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Nephrology
Zip code
810-8563
Address
1-8-1 Jigyohama, Chuo-Ku,Fukuoka 810-8563,Japan
TEL
092-852-0700
Homepage URL
nakayama.masaru.kv@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyushu Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kyushu Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyushu Medical Center research ethics committee
Address
1-8-1 Jigyohama, Chuo-Ku,Fukuoka 810-8563,Japan
Tel
092-852-0700
nakayama.masaru.kv@mail.hosp.go.jp
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
| 2015 | Year | 05 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
http://journals.lww.com/jhypertension/Abstract/2016/04000/Plasma_B_type_natriuretic_peptide_concentr
Number of participants that the trial has enrolled
Results
Plasma B-type natriuretic peptide concentration is independently associated
with kidney function decline in Japanese patients with chronic kidney
disease.
Yoshitomi R, Nakayama M, Sakoh T, Fukui A, Shikuwa Y, Tominaga M,
Tsuchihashi T, Tsuruya K, Kitazono T.
J Hypertens. 2016 Apr;34(4):753-61.
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
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
consecutive sampling
Management information
Registered date
| 2015 | Year | 05 | Month | 12 | Day |
Last modified on
| 2019 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020304
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
