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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043594
Receipt No. 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 2021/03/11

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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
Institute St. Marianna University School of Medicine
Institute
Department

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 Open public 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

Management information
Registered date
2021 Year 03 Month 11 Day
Last modified on
2021 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.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


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