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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047714


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name