UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041796 |
|---|---|
| Receipt number | R000047714 |
| Scientific Title | Evaluation of the reno-protective effect of multidisciplinary team care in patients with diabetes-induced Chronic kidney disease |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2021/03/18 02:55:25 |
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Basic information
Public title
Evaluation of the reno-protective effect of multidisciplinary team care in patients with diabetes-induced Chronic kidney disease
Acronym
Evaluation of the reno-protective effect of multidisciplinary team care in patients with diabetes-induced Chronic kidney disease
Scientific Title
Evaluation of the reno-protective effect of multidisciplinary team care in patients with diabetes-induced Chronic kidney disease
Scientific Title:Acronym
Evaluation of the reno-protective effect of multidisciplinary team care in patients with diabetes-induced Chronic kidney disease
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will identify the factors related to the occurrence of renal event 5 years after intervention of multidisciplinary team care for diabetes-induced chronic kidney disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Renal event is defined as the doubling of serum creatinine level, the initiation of renal replacement therapy, and death due to end-stage renal dysfunction.
2.To examine the cumulative incidence ratio of renal event during 5 years observation period after multidisciplinary team care.
3 To identify the beneficial or risk factors related to the occurrence of renal event.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with stage 3 or higher chronic kidney disease (eGFR <60 mL/min/1.73 m2) caused by diabetes without hemodialysis
Key exclusion criteria
1. Cases with malignancy upon enrollment of the trial
2. Cases with active infections upon enrollment of the trial
3. Patients who did not agree to participate in this clinical trial
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Ino |
Organization
Toda Central General Hospital
Division name
Department of Nephrology
Zip code
335-0023
Address
1-19-3 Hon-cho, Toda city, Saitama, 335-0023, Japan
TEL
048-442-1111
pikkun46@hotmail.com
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Ino |
Organization
Toda Central General Hospital
Division name
Department of Nephrology
Zip code
335-0023
Address
1-19-3 Hon-cho, Toda city, Saitama, 335-0023, Japan
TEL
048-442-1111
Homepage URL
pikkun46@hotmail.com
Sponsor or person
Institute
Toda Central General Hospital
Institute
Department
Personal name
Funding Source
Organization
Toda Central General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Toda Central General Hospital
Address
1-19-3 Hon-cho, Toda city, Saitama, 335-0023, Japan
Tel
048-442-1111
iryouhisho@chuobyoin.or.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
| 2020 | Year | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Intervention of multidisciplinary team care for chronic kidney disease due to diabetes will be conducted to examine the effect on the occurrence of renal event during five-year observational period. In particular, among guidance contents of multidisciplinary team care, we will identify the factors that contributes to the effect of suppressing the occurrence of renal event and the risk factors that promotes the occurrence of the event.
Management information
Registered date
| 2020 | Year | 09 | Month | 15 | Day |
Last modified on
| 2021 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047714
