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 | 2024/09/24 11:11:44 |
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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
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
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
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
Completed
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
| 2024 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049779
