UMIN-ICDS Clinical Trial

Public title

The effectiveness of multidisciplinary care for patients with chronic kidney disease in Japan

Acronym

The effectiveness of multidisciplinary care for patients with chronic kidney disease

Scientific Title

The effectiveness of multidisciplinary care for patients with chronic kidney disease in Japan

Scientific Title:Acronym

Effectiveness of multidisciplinary care for patients with CKD

Region

Japan

Condition

Chronic Kidney Disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To determine whether multidisciplinary care could help prevent worsening kidney function in patients with chronic kidney disease.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary efficacy endpoint was the annual decline in eGFR (changes in eGFR) between before 12 months and after 24 months intervention by multidisciplinary care.

Key secondary outcomes

Secondary endpoints included annual changes in urinary protein levels between before 12 months and after 24 months intervention by multidisciplinary care, and composite outcome, including all-cause mortality and initiation of renal replacement therapy.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Chronic kidney disease (CKD) who received multidisciplinary care in Japan between January 2015 to December 2020, and patients with CKD receiving intervention by continuous multidisciplinary care and kidney function data available for 12 months before and after receiving multidisciplinary care.

Key exclusion criteria

Exclusion criteria were age less than 20 years, eGFR more than 60mL/min/1.73m2, active cancer, transplant recipients and patients who previously have undergone chronic dialysis, and missing data on age, gender, or kidney function.

Target sample size

3000

Name of lead principal investigator

1st name	Masanori
Middle name
Last name	Abe

Organization

Nihon University Itabashi Hospital

Division name

Division of Nephrology, Hypertension and Endocrinology, Department of Medicine

Zip code

173-8610

Address

30-1, Oyaguchi Kami-cho, Itabashi-ku, Tokyo, Japan

TEL

03-3972-8111

Email

abe.masanori@nihon-u.ac.jp

Name of contact person

1st name	Masanori
Middle name
Last name	Abe

Organization

Nihon University Itabashi Hospital

Division name

Division of Nephrology, Hypertension and Endocrinology, Department of Medicine

Zip code

173-8610

Address

30-1, Oyaguchi Kami-cho, Itabashi-ku, Tokyo, Japan

TEL

+81339728111

Homepage URL

Email

abe.masanori@nihon-u.ac.jp

Institute

Nihon University

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nihon University Itabashi Hospital

Address

30-1, Oyaguchi Kami-cho, Itabashi-ku, Tokyo, Japan

Tel

03-3972-8111

Email

abe.masanori@nihon-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

01

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

3015

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

Recruitment status

No longer recruiting

Date of protocol fixation

2021

Year

09

Month

30

Day

Date of IRB

2022

Year

05

Month

13

Day

Anticipated trial start date

2021

Year

10

Month

01

Day

Last follow-up date

2022

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Data were collected on patients demographic and clinical characteristics, including age, sex, history of cardiovascular disease, primary diseases of CKD, body mass index (BMI), hemoglobin, serum albumin, urea nitrogen, creatinine, estimated glomerular filtration rate (eGFR), urinary protein, and glycated hemoglobin for diabetes patients at initiating intervention by multidisciplinary care. Cardiovascular disease (CVD) was defined as coronary artery disease, ischemic stroke, hemorrhagic stroke, and limb amputation. Urinary protein was calculated as urinary protein to creatinine ratio. The eGFR and UPCR values were obtained at 12 months before the intervention by multidisciplinary care, and at 6 months, 12 months, and 24 months after the intervention. Method and place of intervention (outpatient or inpatient), duration of intervention (number of visits for intervention for outpatients or hospitalization days for inpatients), type and number of stuffs were collected. Composite outcomes, including dates of death or initiation of RRT, were recorded until the composite endpoint is reached or the end of 2021, whichever comes earlier. Furthermore, types of RRT, which are hemodialysis, peritoneal dialysis, or kidney transplantation, were recorded.

Registered date

2023

Year

01

Month

09

Day

Last modified on

2023

Year

01

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056941