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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022145
Receipt No. R000025521
Scientific Title A nationwide prospective cohort study of patients with advanced chronic kidney disease (CKD G3b-G5) in Japan
Date of disclosure of the study information 2016/04/30
Last modified on 2020/01/31

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Basic information
Public title A nationwide prospective cohort study of patients with advanced chronic kidney disease (CKD G3b-G5) in Japan
Acronym REACH-J-CKD cohort
Scientific Title A nationwide prospective cohort study of patients with advanced chronic kidney disease (CKD G3b-G5) in Japan
Scientific Title:Acronym REACH-J-CKD cohort
Region
Japan

Condition
Condition advanced chronic kidney disease patients(CKDG3b-5)
Classification by specialty
Medicine in general Nephrology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the prognosis and practice patterns of advanced CKD patients in Japan.
Basic objectives2 Others
Basic objectives -Others cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Initiation of Renal replacement therapy (hemodialysis, peritoneal dialysis,renal transplantation) and/or death
Key secondary outcomes 1) More than 30% deterioration of eGFR
2) More than 50% deterioration of eGFR
3) transition to CKD G5(eGFR<15 ml/min/1.73m2)
4) the onset of cardiovascular disease(angina pectoris, myocardial infarction, cerebral infarction, cerebral hemorrhage, limb amputation)

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 have agreed to participate in our study with written form.
2) outpatient
3)CKD G3b-5(GFR less than 45ml/min/1.73m2)
Key exclusion criteria 1) Patients who had medical history of renal replacement therapy or under renal replacement therapy
2) Patients who are considered inadequate for the study.
Target sample size 2400

Research contact person
Name of lead principal investigator
1st name Yamagata
Middle name
Last name Kunihiro
Organization University of Tsukuba
Division name Department of Nephrology, Faculty of Medicine
Zip code 3058575
Address 1-1-1, Ten-oudai, Tsukuba, 305-8575, Japan
TEL +81-29-853-3200
Email k-yamaga@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name Saito
Middle name
Last name Chie
Organization University of Tsukuba
Division name Department of Nephrology, Faculty of Medicine
Zip code 3058575
Address 1-1-1, Ten-oudai, Tsukuba, 305-8575, Japan
TEL +81-29-853-3200
Homepage URL http://reach-j.jp/
Email chie.saito@md.tsukuba.ac.jp

Sponsor
Institute Department of Nephrology, Faculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization Grant-in-Aid for Research on Advanced Chronic Kidney Disease(REACH-J), Practical Research Project for Renal Diseases from Japan Agency for Medical Research and development, AMED
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Niigata University(Niigata), Nagoya University(Nagoya), Okayama University(Okayama), Kawasaki Medical School(Okayama), Kitasaito Hospital(Hokkaido), Kyoto prefectural of medicine(Kyoto), Nantan General Hospital(Kyoto), Kyushu University(Fukuoka), Nagasaki Municipal Medical Center(Nagasaki), University of Tsukuba(Ibaraki), Funabashi Futawa Hospital(Chiba), Shonan Kamakura General Hospital(Kanagawa), Shinmatsudo Central General Hospital(Chiba), Kagawa University(Kagawa), Osaki Citizen Hospital(Miyagi), Nihon University(Tokyo), Nagoya City West Medical Center(Aichi), Inoue Hospital(Osaka), Kobe University(Hyogo), JR Sapporo Hospital(Hokkaido), Shiigai clinic(Ibaraki), Shinonoi General Hospital(Nagano), Toho Hospital(Gunma), Kikkawa Clinic(Saitama), Nagaoka Red Cross Hospital(Niigata), Tokuyama Clinic(Okinawa), Miyazaki University(Miyazaki), NTT East Medical Center Tokyo(Tokyo), Nara Prefecture General Medical Center (Nara),Akashi Medical Center(Hyogo),Kichijoji Asahi Hospital(Tokyo),Saiseikai Toyama Hospital(Toyama)
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tsukuba Clinical Research & Development Organization
Address Tsukuba city, Amakubo, 2-1-1
Tel 0298533914
Email rinshokenkyu@un.tsukuba.ac.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 新潟大学医歯学総合病院 (新潟県)、名古屋大学医学部附属病院(愛知県)、 岡山大学病院(岡山県)、 川崎医科大学附属病院(岡山県)、医療法人仁友会 北彩都病院(北海道)、京都府立医科大学附属病院(京都府)、公立南丹病院(京都府)、九州大学病院(福岡県)、長崎みなとメディカルセンター市民病院(長崎県)、筑波大学附属病院(茨城県)、千葉県勤労者医療協会 船橋二和病院(千葉県)、医療法人沖縄徳洲会湘南鎌倉総合病院(神奈川県)、医療法人財団明理会新松戸中央総合病院(千葉県)、香川大学医学部附属病院(香川県)、大崎市民病院(宮城県)、日本大学病院(東京都)、名古屋市立西部医療センター(愛知県)、医療法人蒼龍会 井上病院(大阪府)、神戸大学医学部附属病院(兵庫県)、JR札幌病院(北海道)、椎貝クリニック(茨城県)、JA長野厚生連篠ノ井総合病院 (長野県)、医療法人社団三思会 東邦病院(群馬県)、きっかわ内科クリニック(埼玉県)、長岡赤十字病院(新潟県)、医療法人清心会 徳山クリニック(沖縄県)、宮崎大学(宮崎県)、NTT東日本関東病院(東京都)、明石医療センター(兵庫県)、吉祥寺あさひ病院(東京都)、富山県済生会富山病院(富山県)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 2249
Results
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 No longer recruiting
Date of protocol fixation
2016 Year 02 Month 02 Day
Date of IRB
2015 Year 12 Month 14 Day
Anticipated trial start date
2016 Year 02 Month 03 Day
Last follow-up date
2022 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Under recruitment of participants

Management information
Registered date
2016 Year 04 Month 30 Day
Last modified on
2020 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025521

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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