UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043594
Receipt number R000049779
Scientific Title Health maintenance of renal transplant recipient and donor by multi-disciplinary care.
Date of disclosure of the study information 2021/03/11
Last modified on 2023/09/12 10:12:19

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Basic information

Public title

Health maintenance of renal transplant recipient and donor by multi-disciplinary care.

Acronym

Health maintenance of renal transplant recipient and donor by multi-disciplinary care.

Scientific Title

Health maintenance of renal transplant recipient and donor by multi-disciplinary care.

Scientific Title:Acronym

Health maintenance of renal transplant recipient and donor by multi-disciplinary care.

Region

Japan


Condition

Condition

End-stage renal failure

Classification by specialty

Nephrology Urology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will investigate the effect of multi-disciplinary care on Health maintenance of renal transplant recipient and donor.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

CKD progression after the intervention

Key secondary outcomes

Improvement of metabolic syndrome after the intervention
Improvement of sarcopenia after the intervention


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Patients in the exercise group will undergo aerobic training or walking. Aerobic training will be prescribed three times a week with the intensity of Borg Scale of 11 to 13 and walking will be prescribed as 8,000 to 10,00 0 steps every day.

Interventions/Control_2

None

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

Kidney transplant recipient and donor

Key exclusion criteria

Patients with exercise restriction by a medical doctor
Patients with a pacemaker
Patients judged inappropriate by a medical doctor

Target sample size

140


Research contact person

Name of lead principal investigator

1st name Naohiko
Middle name
Last name Imai

Organization

St. Marianna University School of Medicine

Division name

Division of Nephrology and Hypertension

Zip code

216-8511

Address

2-16-1 Sugao, Miyamae-Ku, Kawasaki-shi ,Kanagawa

TEL

+81-044-977-8111

Email

naohiko.imai@gmail.com


Public contact

Name of contact person

1st name Yoko
Middle name
Last name Fujita

Organization

St. Marianna University School of Medicine

Division name

Division of Nephrology and Hypertension

Zip code

216-8511

Address

2-16-1 Sugao, Miyamae-Ku, Kawasaki-shi ,Kanagawa

TEL

+81-044-977-8111

Homepage URL


Email

y2fujita@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

St. Marianna University School of Medicine

Address

2-16-1 Sugao, Miyamae-Ku, Kawasaki-shi ,Kanagawa

Tel

+81-044-977-8111

Email

k-sienbu.mail@marianna-u.ac.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

聖マリアンナ医科大学


Other administrative information

Date of disclosure of the study information

2021 Year 03 Month 11 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

No longer recruiting

Date of protocol fixation

2021 Year 03 Month 11 Day

Date of IRB

2021 Year 02 Month 17 Day

Anticipated trial start date

2021 Year 03 Month 11 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Analyzing data


Management information

Registered date

2021 Year 03 Month 11 Day

Last modified on

2023 Year 09 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049779


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name