UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004461 |
|---|---|
| Receipt number | 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 12:08:07 |
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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
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
ynodmed2@tmd.ac.jp
Sponsor or person
Institute
Department of Nephrology, Tokyo Medical and Dental University
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
Hospitals cooperated with Department of Nephrology, Tokyo Medical and Dental University
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004862
