UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email	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	Open public recruiting
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 03 Month 31 Day
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	2019 Year 10 Month 28 Day
Last modified on	2020 Year 04 Month 21 Day

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

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