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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000038415 |
Receipt No. | 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 | 2020/04/21 |
Basic information | ||
Public title | Randomized, Parallel Group, Non-intervention-controlled Evaluation of the Efficacy of Exercise Therapy for Patients
with CKD |
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Acronym | Evaluation of the Efficacy of Exercise Therapy for Patients with CKD
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Scientific Title | Randomized, Parallel Group, Non-intervention-controlled Evaluation of the Efficacy of Exercise Therapy for Patients
with CKD |
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Scientific Title:Acronym | Evaluation of the Efficacy of Exercise Therapy for Patients with CKD | |
Region |
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Condition | |||
Condition | Chronic kidney disease | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 46 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | International University of Health and Welfare |
Institute | |
Department |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043754 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |