UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	CKD Research of Outcomes in Treatment and Epidemiology
Title of the study (Brief title)	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	Sei Sasaki
Organization	Tokyo Medical and Dental University
Division name	Department of Nephrology
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	Yumi Noda
Organization	Tokyo Medical and Dental University
Division name	Department of Chronic Kidney Disease
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 10 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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/icdr_e/ctr_view.cgi?recptno=R000004862