UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Low-power extracorporeal shock wave therapy for improvement of blood pressure and suppression of renal function reduction in CKD patients diagnosed as chronic kidney disease (CKD) stage 3, 4
Title of the study (Brief title)	ESWT-CKD
Region	Japan

Condition
Condition	CKD stage 3 &4 patients
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	By using an extracorporeal shock wave device, we evaluate the effectiveness of low power extracorporeal shock wave therapy for improving blood pressure, an important risk factor of CKD progression, in CKD stage 3 &4 patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	improvement of mean blood pressure
Key secondary outcomes	improvement of eGFR

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Extracorporeal Shock Wave
Interventions/Control_2	control
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	18 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	CKD stage 3 & 4 patients with at least one history of hypertension, diabetes, dyslipidemia, smoking history, cardiovascular complications
Key exclusion criteria	Patients with a local skin infection at the contact site with the applicator Patients with bleeding tendency Patients with urolithiasis or kidney stones Patients with hydronephrosis Patients with active pyelonephritis Patients with cancer Patients treated with steroids or immunosuppressants Patients who is expected to introduce dialysis within 12 weeks Polycystic kidney disease patients Patients with renal morphological abnormality Patients who received kidney transplantation Dialysis patients (HD, PD) Patients whose renal blood flow cannot be evaluated Objects considered by the attending physician as inappropriate
Target sample size	66

Research contact person
Name of lead principal investigator	Yoshitaka Isaka
Organization	Osaka University Graduate School of Medicine
Division name	Nephrology
Address	2-2, Yamadaoka, Suita
TEL	0668793857
Email	isaka@kid.med.osaka-u.ac.jp

Public contact
Name of contact person	Yoshitaka Isaka
Organization	Osaka University Graduate School of Medicine
Division name	Nephrology
Address	2-2, Yamadaoka, Suita
TEL	0668793857
Homepage URL
Email	isaka@kid.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 01 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 18 Day
Last modified on	2017 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034765