UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004461
Receipt No. R000004862
Scientific Title CKD Research of Outcomes in Treatment and Epidemiology
Date of disclosure of the study information 2010/10/27
Last modified on 2017/12/27

* 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 CKD Research of Outcomes in Treatment and Epidemiology
Acronym CKD-ROUTE Study
Scientific Title CKD Research of Outcomes in Treatment and Epidemiology
Scientific Title:Acronym CKD-ROUTE Study
Region
Japan

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

Objectives
Narrative objectives1 This survey evaluates the relationship of endpoints to patient characteristics, complications and treatment and examines risk factors for CKD progression and poor prognosis to contribute development of appropriate therapy for CKD.
Basic objectives2 Others
Basic objectives -Others A prospective cohort study
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Decline in renal function defined by reduction in estimated GFR
Key secondary outcomes Cardiovascular events
Renal replacement therapy
Death from cardiovascular events
Death from any cause without accident
Fractures (Fractures associated with major trauma, such as motor vehicle accidents are excluded.)
Hospitalization
Changes in the levels of WBC, Hb , Plt, TP, Alb, BUN, Cr, Na, K, Cl, Ca, P, Alp, T-Chol, TG, HDL, CK, Glu, HbA1c, Fe, UIBC (or TIBC), ferritin, CRP, intact PTH.
Changes in the levels of urinary protein and urinary blood
Changes in blood pressure
Changes in the values of body weight and BMI

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 All new patients with non-dialysis CKD (stage 2, 3, 4 and 5) at the participating nephrology departments, who will likely to be followed by nephrologists for at least 1 year, and who provide written informed consent to participate in the present survey.
Key exclusion criteria Cancer
History of organ transplantation
Active gastrointestinal bleeding
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sei Sasaki
Organization Tokyo Medical and Dental University
Division name Department of Nephrology
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519 Japan
TEL 03-5803-5214
Email ssasaki.kid@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumi Noda
Organization Tokyo Medical and Dental University
Division name Department of Chronic Kidney Disease
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519 Japan
TEL 03-5803-5214
Homepage URL
Email ynodmed2@tmd.ac.jp

Sponsor
Institute Department of Nephrology, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Hospitals cooperated with Department of Nephrology, Tokyo Medical and Dental University
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 東京医科歯科大学医学部付属病院腎臓内科および下記関連施設
取手協同病院、秀和綜合病院、中野総合病院、都立多摩総合医療センター、都立墨東病院、横須賀共済病院、都立大塚病院、武蔵野赤十字病院、平塚共済病院、東京共済病院、土浦協同病院、都立広尾病院、青梅市立総合病院、豊島病院、千葉東病院

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Iimori S, Noda Y, Okado T, Naito S, Toda T, et al. Baseline characteristics and prevalence of cardiovascular disease in newly visiting or referred chronic kidney disease patients to nephrology centers in Japan: a prospective cohort study. BMC Nephrol. 17;14:152, 2013. 

Iimori S, Naito S, Noda Y, Nishida H, Kihira H, et al. Anaemia management and mortality risk in newly visiting patients with chronic kidney disease in Japan: The CKD-ROUTE study. Nephrology. 20:601-608, 2015. 

Kikuchi H, Kanda E, Mandai S, Akazawa M, Iimori S, et al. Combination of low body mass index and serum albumin level is associated with chronic kidney disease progression: the chronic kidney disease-research of outcomes in treatment and epidemiology (CKD-ROUTE) study. Clin Exp Nephrol. 21:55-62, 2016. 

Mandai S, Kanda E, Iimori S, Naito S, Noda Y, et al. Association of serum chloride level with mortality and cardiovascular events in chronic kidney disease: the CKD-ROUTE study. Clin Exp Nephrol. 21:104-111, 2017.

Arai Y, Kanda E, Iimori S, Naito S, Noda Y, et al. The use of vitamin D analogs is independently associated with the favorable renal prognosis in chronic kidney disease stages 4-5: the CKD-ROUTE study. Clin. Exp. Nephrol. 21:481-487, 2017.

Arai Y, Kanda E, Iimori S, Naito S, Noda Y, et al. Low white blood cell count is independently associated with chronic kidney disease progression in the elderly: the CKD-ROUTE study. Clin. Exp. Nephrol. 2017.

Iimori S, Naito S, Noda N, Sato H, Nomura N, et al. Prognosis of chronic kidney disease with normal-range proteinuria: The CKD-ROUTE study. PLoS One 2018.
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 Main results already published
Date of protocol fixation
2010 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2015 Year 01 Month 31 Day
Date of closure to data entry
2015 Year 07 Month 31 Day
Date trial data considered complete
2015 Year 07 Month 31 Day
Date analysis concluded

Other
Other related information A prospective cohort study

Management information
Registered date
2010 Year 10 Month 27 Day
Last modified on
2017 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004862

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.