UMIN-CTR Clinical Trial

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

Condition
Condition	diabetic kidney disease patients
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	y using an extracorporeal shock wave device, we evaluate the safety of low power extracorporeal shock wave therapy for suppressing renal function reductio in CKD stage 3 type2 diabetic kidney disease patients.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Extracorporeal Shock Wave
Interventions/Control_2
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 type 2 diabetic kidney disease patients
Key exclusion criteria	Patients with bleeding tendency Patients with urolithiasis or kidney stones Patients with hydronephrosis Patients with active pyelonephritis Patients with cancer Objects considered by the attending physician as inappropriate
Target sample size	6

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	Japanese Governmental office
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	2018 Year 01 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 10 Day
Anticipated trial start date	2014 Year 07 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	2018 Year 01 Month 11 Day
Last modified on	2018 Year 01 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035134