UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016576
Receipt No. R000019119
Scientific Title Evaluation of effectiveness and safety of transcatheter renal arterial embolization with microspheres for polycystic kidney disease
Date of disclosure of the study information 2015/02/23
Last modified on 2016/08/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of effectiveness and safety of transcatheter renal arterial embolization with microspheres for polycystic kidney disease
Acronym Renal arterial embolization with microspheres for polycystic kidney disease
Scientific Title Evaluation of effectiveness and safety of transcatheter renal arterial embolization with microspheres for polycystic kidney disease
Scientific Title:Acronym 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
1st name
Middle name
Last name Yusuke Sakuhara
Organization Hokkaido University Hospital
Division name Diagnostic and Interventional Radiology
Zip code
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
1st name
Middle name
Last name Yusuke Sakuhara
Organization Hokkaido University Hospital
Division name Diagnostic and Interventional Radiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 No longer recruiting
Date of protocol fixation
2015 Year 02 Month 05 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000019119

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.