UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038415 |
|---|---|
| Receipt number | R000043754 |
| Scientific Title | Randomized, Parallel Group, Non-intervention-controlled Evaluation of the Efficacy of Exercise Therapy for Patients with CKD |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2023/03/26 12:40:36 |
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Basic information
Public title
Randomized, Parallel Group, Non-intervention-controlled Evaluation of the Efficacy of Exercise Therapy for Patients
with CKD
Acronym
Evaluation of the Efficacy of Exercise Therapy for Patients with CKD
Scientific Title
Randomized, Parallel Group, Non-intervention-controlled Evaluation of the Efficacy of Exercise Therapy for Patients
with CKD
Scientific Title:Acronym
Evaluation of the Efficacy of Exercise Therapy for Patients with CKD
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the efficacy of exercise therapy for patients with chronic kidney disease
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
eGFRCr
Key secondary outcomes
Serum concentrations of albumin, creatinine and cystatin C
Urinary concentrations of protein, albumin, B2MG, L-FABP, NGAL, creatinine, and cystatin C, KIM1
PWV
ABI
DEX
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Treatment group: Aerobic exercise and muscle training will be provided for each patient during the study period (24 weeks).
Interventions/Control_2
Control group: Obtain the record of voluntary exercise from each patient.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
CKD patients in whom the cause of renal impairment was examined by renal biopsy
Key exclusion criteria
Requirement for steroid therapy
CKD stage IV, V
Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg)
Severe anemia (Hb < 7 g/dL)
BMI > 30
Active proliferative diabetic retinopathy
Onset of coronary disease or cerebrovascular disease with in the previous 3 months
Uncontrolled heart failure (NYHA Class III or worse)
Difficulty walking
Other conditions that make patients unsuitable for the study in the investigator's opinion
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Washida |
Organization
International University of Health and Welfare
Division name
Nephrology
Zip code
286-8686
Address
4-3 Kozunomori Narita City
TEL
+81-476-20-7701
washida@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Takahide |
| Middle name | |
| Last name | Kimura |
Organization
International University of Health and Welfare Atami Hospital
Division name
Nephrology
Zip code
413-0012
Address
13-1 Hgashikaigancho Atami City
TEL
+81-557-81-9171
Homepage URL
t.kimura@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
International University of Health and Welfare Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Institutional Review Board
Address
4-3 Kozunomori Narita City
Tel
+81-476-20-7703
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(静岡県)、国際医療福祉大学病院(栃木県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 01 | 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
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 01 | Day |
Other
Other related information
We will start the exercise therapy after three months evaluation of eGFRCr.
We will exclude the patients who will necessitate dosage change of Angiotensin II Receptor Blockers and Angiotensin converting enzyme inhibitors during the examination.
Management information
Registered date
| 2019 | Year | 10 | Month | 28 | Day |
Last modified on
| 2023 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043754
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
