UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016576 |
|---|---|
| Receipt number | 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 15:54:10 |
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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)
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
yusaku@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Diagnostic and Interventional Radiology, Hokkaido University Hospital
Clinical Research and Medical Innovation Center, Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019119
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
