UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000022145 |
|---|---|
| Receipt number | 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 | 2024/05/07 13:09:14 |
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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
+81-29-853-3202
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
+81-29-853-3202
Homepage URL
http://reach-j.jp/
chie.saito@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Nephrology, Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
AMED
Kyowa Kirin Co., Ltd
Mitsubishi Tanabe Pharma Co., Ltd
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 University 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
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）、地方独立行政法人長崎市立病院機構 長崎みなとメディカルセンター（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）、名古屋市立大学医学部附属西部医療センター（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
| Delay expected |
Results Delay Reason
Under analysis
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
| 2016 | Year | 01 | Month | 07 | 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
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Under recruitment of participants
Management information
Registered date
| 2016 | Year | 04 | Month | 30 | Day |
Last modified on
| 2024 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025521
