UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of effectiveness and safety of transcatheter renal arterial embolization with microspheres for polycystic kidney disease
Title of the study (Brief title)	Renal arterial embolization with microspheres for polycystic kidney disease
Region	Japan

Condition
Condition	Polycystic kidney disease
Classification by specialty	Nephrology Urology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and effectiveness of transcatheter arterial embolization with microspheres for patients with symptomatic enlarged polycystic kidneys.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The volume reduction rate of the kidneys at three months after renal arterial embolization
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	12 months follow up 1 session embolization treatment Complete occlusion of the targeted vessels with transcatheter microspheres injection
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Age greater than 20 years 2) Enlargement of polycystic kidneys on computed tomography (CT), magnetic resonance imaging (MRI), or ultrasonography (US), and suggestive symptoms related to polycystic kidneys such as markedly distended abdomen, gastroesophageal reflux, respiratory disorder, abdominal and/or low back pain, hematuria, and repetitive infectious cystitis 3) Already introduced to dialysis therapy for chronic renal failure 4) Urinary volume < 500 mL/day 5) Performance Status (ECOG) 0, 1, or 2 6) Provided enough written and oral information about this study, and given written informed consent to be registered in this study and undergo the procedure
Key exclusion criteria	1) Active inflammatory disease 2) Past history of malignant disease (except for carcinoma in situ) within five years before registration 3) Uncontrollded comorbid disease in the kidney, liver or heart. 4) Contraindication to iodized contrast material 5) Allergy to components (acrylic polymer and porcin gelatin) of microspheres (Embosphere) 6) Massive thoracic effusion 7) Massive ascites 8) Past history of renal arterial embolization 9) Hemoglobin < 8g/dL 10) Platelet count < 50,000 /mm3 11) Abnormalities in 12-led electrocardiogram (excluding clinically not significant abnormalities) 12) Pregnant or possibility being pregnant 13) Judged being not suitable by the principal or sub investigators
Target sample size	5

Research contact person
Name of lead principal investigator	Yusuke Sakuhara
Organization	Hokkaido University Hospital
Division name	Diagnostic and Interventional Radiology
Address	N-14, W-5, Kita-ku, Sapporo
TEL	011-716-1161(5977)
Email	yusaku@med.hokudai.ac.jp

Public contact
Name of contact person	Yusuke Sakuhara
Organization	Hokkaido University Hospital
Division name	Diagnostic and Interventional Radiology
Address	N-14, W-5, Kita-ku, Sapporo
TEL	011-716-1161(5977)
Homepage URL
Email	yusaku@med.hokudai.ac.jp

Sponsor
Institute	Department of Diagnostic and Interventional Radiology, Hokkaido University Hospital Clinical Research and Medical Innovation Center, Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
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	2015 Year 02 Month 23 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 02 Month 05 Day
Anticipated trial start date	2015 Year 02 Month 23 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	2015 Year 02 Month 18 Day
Last modified on	2016 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019119