UMIN-CTR Clinical Trial

Basic information
Public title	Intensified multifactorial intervention on renal outcomes in DKD outpatients
Acronym	Intensified multifactorial intervention on renal outcomes in DKD outpatients
Scientific Title	Intensified multifactorial intervention on renal outcomes in DKD outpatients
Scientific Title:Acronym	Intensified multifactorial intervention on renal outcomes in DKD outpatients
Region	Japan

Condition
Condition	Diabetic kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effeciveness of outpatient intensive treatment and management targets sheet for the prognosis of diabetic kidney disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	end stage kidney disease
Key secondary outcomes	anunual eGFR change rate,MACE,urinary protein change,achievement level of management targets sheet

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Outpatient-intensive treatment by using a management target sheet (+)
Interventions/Control_2	Outpatient-intensive treatment by using a management target sheet (-)
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	18 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients who have a new visit to the Department of Nephrology and are scheduled to go to the hospital for more than half a year 2) Diabetic patients in the course of diabetic kidney disease 3) Diabetic nephropathy stage 2 to 4 4) Patients who are 18 years old or older and younger than 90 years old at the time of registration 5) Gender: Any gender 6) General condition that allows medical care in an outpatient setting 7) Patients who have no complications of heart, brain or vascular disease or are in a stable condition 8) Patients whose written consent was obtained by the patient's own free will
Key exclusion criteria	1) Patients who require hospitalization or new treatment at the time of registration 2) Patients suffering from serious malignant diseases, infections, heart, brain, blood vessels, liver diseases 3) Patients suffering from malignant diseases, infectious diseases, heart, brain, blood vessels, and liver diseases that are considered to have a limited life prognosis within half a year 4) Patients with eGFR of 15 ml / min or less and uremic symptoms 5) Female patients who are pregnant or may be pregnant 6) Patients with primary chronic glomerulonephritis (IgA nephropathy, membranous nephropathy, minimal change nephrosis) 7) Patients with purpura nephropathy, lupus nephritis, systemic vasculitis 8) Patients with acute renal failure at the time of registration 9) Patients who have prerenal failure and postrenal failure at the time of registration 10) When the research supervisor or research director determines that participation in this research is not appropriate
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Honami Middle name Last name Mori
Organization	JCHO Saitama Northern Medical Center
Division name	Department of Nephropathy
Zip code	3318625
Address	1-851, Miyahara-cho, Kita-ku, Saitama City, Saitama
TEL	0486631671
Email	honamimori33@gmail.com

Public contact
Name of contact person	1st name Honami Middle name Last name Mori
Organization	JCHO Saitama Northern Medical Center
Division name	Department of Nephropathy
Zip code	3318625
Address	1-851, Miyahara-cho, Kita-ku, Saitama City, Saitama
TEL	0486631671
Homepage URL
Email	honamimori33@gmail.com

Sponsor
Institute	Japan community healthcare organization
Institute
Department

Funding Source
Organization	Japan community healthcare organization reseach business
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	JPN

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

IRB Contact (For public release)
Organization	JCHO Central Ethics Review Committee
Address	3-22-12, Takanawa, Minato-ku, Tokyo
Tel	0334450862
Email	iryoka@jcho.go.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

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 15 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
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	Preinitiation
Date of protocol fixation	2019 Year 10 Month 15 Day
Date of IRB	2019 Year 08 Month 22 Day
Anticipated trial start date	2019 Year 11 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 02 Day
Last modified on	2019 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043056