UMIN-CTR Clinical Trial
| Recruitment status | Enrolling by invitation |
| Unique ID issued by UMIN | UMIN000017519 |
| Receipt No. | 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 (Ver. 8) |
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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 |
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| Condition | ||
| Condition | Chronic kidney disease | |
| Classification by specialty |
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| 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 | |
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| 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 | |
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| Interventions/Control_10 | |
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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. |
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| 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. |
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| Target sample size | 99999 | |||
| Research contact person | |||||||
| Last name of lead principal investigator |
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| Organization | National Hospital Organization Kyushu Medical Center
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| 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 | |||||||
| 1st name of contact person |
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| 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 | |
| Institute | National Hospital Organization Kyushu Medical Center |
| Institute | |
| Department | |
| 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 | |
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| Date of disclosure of the study information |
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| 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 |
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| Date of IRB |
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| Anticipated trial start date |
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| Date analysis concluded | |||||||
| Other | |
| Other related information | prospective study
consecutive sampling |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020304 |
