UMIN-CTR Clinical Trial

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
Email	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
Email	pikkun46@hotmail.com

Sponsor
Institute	Toda Central General Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047714