UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037889 |
|---|---|
| Receipt number | R000043056 |
| Scientific Title | Intensified multifactorial intervention on renal outcomes in DKD outpatients |
| Date of disclosure of the study information | 2019/10/15 |
| Last modified on | 2019/09/02 12:21:42 |
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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
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
honamimori33@gmail.com
Sponsor or person
Institute
Japan community healthcare organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043056
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
