UMIN-CTR Clinical Trial

Basic information
Public title	Prospective cohort study of patients with CKD and development of medical system for CKD and CVD
Acronym	Kakusyo CKD/CVD cohort (3C) study
Scientific Title	Prospective cohort study of patients with CKD and development of medical system for CKD and CVD
Scientific Title:Acronym	Kakusyo CKD/CVD cohort (3C) study
Region	Japan

Condition
Condition	Chronic Kidney Disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the current study is to prospective follow patients with CKD including high risk patients for CVD in associated hospitals of Okayama University Hospital, and to evaluate risk factors and predictive factors for progression of CKD, ESRD, CVD onset and death.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Composite renal endpoint (ESRD, 50% reduction of eGFR and death) 2. Onset of cardiovascular events
Key secondary outcomes

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	75 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with chronic kidney disease
Key exclusion criteria	Patients on dialysis and patients receiving renal transplantation
Target sample size	1200

Research contact person
Name of lead principal investigator	1st name Haruhito Middle name A Last name Uchida
Organization	Okayama Univ. Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Dept. of CKD and CVD
Zip code	7008558
Address	2-5-1, Shikata-cho, Kita-ku, Okayama city
TEL	086-235-7235
Email	hauchida@okayama-u.ac.jp

Public contact
Name of contact person	1st name Haruhito Middle name A Last name Uchida
Organization	Okayama Univ. Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Dept. of CKD and CVD
Zip code	7008558
Address	2-5-1,Shikata-cho, Kita-ku, Okayama city
TEL	086-235-7235
Homepage URL
Email	hauchida@okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	Okayama Univ. Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital
Address	2-5-1 Shikata-cho, Kita-ku, Okayama city
Tel	086-235-6503
Email	mae6605@adm.okayama-u.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	岡山大学病院、岡山大学病院関連施設

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 24 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	200
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	To delay in writing manuscript
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	2012 Year 09 Month 01 Day
Date of IRB	2012 Year 10 Month 23 Day
Anticipated trial start date	2013 Year 05 Month 25 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 06 Month 01 Day
Date trial data considered complete	2021 Year 09 Month 01 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information	All data were fixed, and writing manuscript is going

Management information
Registered date	2013 Year 05 Month 23 Day
Last modified on	2022 Year 11 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012632