UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039589 |
|---|---|
| Receipt number | R000045147 |
| Scientific Title | Effect of exercise therapy on residual renal function in incident peritoneal dialysis patients |
| Date of disclosure of the study information | 2020/02/25 |
| Last modified on | 2023/08/29 14:03:08 |
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Basic information
Public title
Effect of exercise therapy on residual renal function in incident peritoneal dialysis patients
Acronym
Effect of exercise therapy on residual renal function in incident peritoneal dialysis patients
Scientific Title
Effect of exercise therapy on residual renal function in incident peritoneal dialysis patients
Scientific Title:Acronym
Effect of exercise therapy on residual renal function in incident peritoneal dialysis patients
Region
| Japan |
Condition
Condition
Chronic Kidney Disease Stage5-D
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will enroll patients initial incident PD to investigate how exercise therapy
affects residual function in the induction phase of PD.
Basic objectives2
Others
Basic objectives -Others
functional mechanisms
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
residual renal function, rGFR (the mean of Urea and Creatinine clearances)
Key secondary outcomes
L-FABP, KIM-1, NGAL, Cystatin C, NAG, beta2 MG,micro albumin to creatinine ratio
Serum Na/K/Cl,Ca/P/PTH intact,UA, TC/HDL/TG,Hb,HbA1c,FOMA-IR,QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
determineed exercise tolerance and optimum home-based exercise therapy. 3times/week
Interventions/Control_2
non-intervention-controlled
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The incident peritonearl dyalisis patients and suit the conditions as below.
1) 30yeas old or more, under 90years old
2) Patients who have been fully informed about participating in this study, have a thorough understanding, and have given their informed consent
Key exclusion criteria
Patients who are contraindicated for exercise therapy (specifically the following)
1. Uncontrolled hypertension (>180 systolic blood pressure or >110 mmHg diastolic blood pressure persistent)
2. Severe anemia (Hb under 7 g/dL)
3. Active proliferative diabetic retinopathy
4. Patients with coronary artery disease or cerebrovascular disease within 3 months
5. Uncontrolled heart failure (NYHA III or higher)
6. People who have difficulty walking
7. Others who are not investigators or those who are inappropriate as study subjects
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Washida |
Organization
International University of Health and Welfare Graduate School of Medicine
Division name
Department of medicine, Clinical research of medicine
Zip code
107-8402
Address
4-1-26, Akasaka, Minato-ku, Tokyo
TEL
03-5574-3900
naoki_washida@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Washida |
Organization
International University of Health and Welfare Graduate School of Medicine
Division name
Department of medicine, Clinical research of medicine
Zip code
107-8402
Address
4-1-26, Akasaka, Minato-ku, Tokyo
TEL
03-5574-3900
Homepage URL
naoki_washida@yahoo.co.jp
Sponsor or person
Institute
International University of Health and Welfare Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of medicine, Keio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethcal Committee of Faculty of medicine, International University of Health and Welfare University
Address
4-3 Kouzunomori, Narita city, CHiba Pref.
Tel
0476-20-7703
rinri_md@iuhw.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
国際医療福祉大学熱海病院、国際医療福祉大学病院、国際医療福祉大学成田病院、慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 25 | 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
70
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
| 2020 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2020 | Year | 02 | Month | 25 | Day |
Last modified on
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045147
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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