UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008096 |
|---|---|
| Receipt number | R000009451 |
| Scientific Title | Evaluation of clinical utility of NF-kB Decoy Oligo coated PTA balloon catheter for arteriovenous fistula stenosis in hemodialysis shunts (AVF) Clinical trial medical device identification number: AMG0102 |
| Date of disclosure of the study information | 2012/06/05 |
| Last modified on | 2015/01/05 10:13:44 |
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Basic information
Public title
Evaluation of clinical utility of NF-kB Decoy Oligo coated PTA balloon catheter for arteriovenous fistula stenosis in hemodialysis shunts (AVF)
Clinical trial medical device identification number: AMG0102
Acronym
Evaluation of clinical utility of NF-kB Decoy Oligo coated PTA balloon catheter for arteriovenous fistula stenosis in hemodialysis shunts (AVF)
Clinical trial medical device identification number: AMG0102
Scientific Title
Evaluation of clinical utility of NF-kB Decoy Oligo coated PTA balloon catheter for arteriovenous fistula stenosis in hemodialysis shunts (AVF)
Clinical trial medical device identification number: AMG0102
Scientific Title:Acronym
Evaluation of clinical utility of NF-kB Decoy Oligo coated PTA balloon catheter for arteriovenous fistula stenosis in hemodialysis shunts (AVF)
Clinical trial medical device identification number: AMG0102
Region
| Japan |
Condition
Condition
Arteriovenous fistula stenosis in hemodialysis shunts
Classification by specialty
| Cardiology | Nephrology | Urology |
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate safety and efficacy of AMG0102 for arteriovenous fistula stenosis in hemodialysis shunts in comparison to conventional PTA balloon catheter.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Duration of primary patency up to 36 weeks after intervention on the targeted venous stenosis site
Key secondary outcomes
Safety, primary patency rate, procedural success, anatomic success, clinical success, patency after repeated AMG0102 intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Percutaneous transluminal angioplasty (PTA)
Interventions/Control_2
NF-kB Decoy Oligo coated PTA balloon catheter
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
Clinical criteria
1.20 years or older, provides written IC
2.Agree if not enrolled within 30 days after IC, another IC is needed.
3.Constructed AVF at least 4 weeks before IC & at least 3 successful HD.
4.Angiography or echo confirms a stenosis determined as targeted lesion & no surgical intervention before.
5.1 Stenosed lesion is of 50% or more stenosis rate and at least one of the below abnormalities is confirmed, and PTA is the best choice.
i. Multiple occurrences of 180ml/min or less blood removal.
ii. Increased in venous pressure by 50mmHg,or 150mmHg pressure persisted constantly.
iii.Efficiency of dialysis by recirculation decreased by 10% or more.
6.The targeted stenosed lesion is 60mm or less in length.
7.In access circuit, no other stenosis 50% or more of stenosis rate exists within 30mm of both sides. If it exists, it must have been treated with PTA alone at least 30 days before IC with residual stenosis rate less than 30% and no complications & the stenosis rate of 30% or less.
8.Can visit for follow up.
Angiographic inclusion criteria:
The stenosis confirms 1 lesion,length 60mm or less & stenosis rate 50% or more.
Key exclusion criteria
Not included if any of the below applies.
1.Stenosis lesion is calcified.
2.Underlying disease for dialysis is SLE nephritis, renal failure associated with congenital metabolic disorders or myeloma, or patient who returns to dialysis after renal transplantation.
3.There is a stenosis within 30mm to the both sides, calcified lesion or varicose located of targeted lesion.
4.Existing stent within the lesion.
5.The targeted stenosis site has been treated with cutting-balloon, etc., & determined as unstable for treatment with AMG0102.
6.Indication to surgical procedure.
7.50% or more central venous stenosis.
8.Cardiac dysfunction by intervention.
9.Unwilling for scheduled follow up.
10.Prognosis as less than 12 months.
11.Pregnant or nursing woman, etc.
12.Dementia
13.Diagnosed malignancy.
14.Allergy or resistance to Heparin.
15.History of life-threatening reaction to contrast medium.
16.Enrolled in another investigational study & follow up evaluation not completed.
17.Systemic infection within 24 hours.
18.Unstable for the study
Target sample size
177
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuichi Morishita MD, PhD |
Organization
Osaka University, Graduate School of Medicine
Division name
Division of Clinical Gene Therapy Science
Zip code
Address
2-2 Yamada-oka, Suita, Osaka
TEL
03-5730-2642
kide@anges-mg.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuki Ide |
Organization
AnGes MG Inc.
Division name
Medical Device Clinical Development Department
Zip code
Address
5-20-14 Shiba Minato-ku Tokyo
TEL
03-5730-2642
Homepage URL
kide@anges-mg.com
Sponsor or person
Institute
AnGes MG, Inc.
Institute
Department
Personal name
Funding Source
Organization
AnGes MG, Inc.
Organization
Division
Category of Funding Organization
Other
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
山梨大学医学部附属病院（山梨県）、福岡赤十字病院（福岡県）、久留米大学医学部附属病院（福岡県）、埼玉医科大学総合医療センター（埼玉県）、静岡県立総合病院（静岡県）、大阪府済生会 富田林病院（大阪府）、東京女子医科大学病院（東京都）、聖マリア病院（福岡県）、新古賀病院（福岡県）、古賀病院21（福岡県）、日高病院（群馬県）、自治医科大学附属さいたま医療センター（埼玉県）、敬愛病院（東京都）、池上総合病院（東京都）、名古屋共立病院、望星平塚クリニック、東名富士クリニック、木町病院、三康病院、友愛日進クリニック、篠ノ井総合病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 05 | 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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | 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
| 2012 | Year | 06 | Month | 04 | Day |
Last modified on
| 2015 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009451
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