UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002033 |
|---|---|
| Receipt number | R000002481 |
| Scientific Title | Clinical effects of H12 hemodialyzer(AN69 membrane) in hemodialysis patients with uremic pruritus |
| Date of disclosure of the study information | 2009/08/31 |
| Last modified on | 2009/06/02 16:18:54 |
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Basic information
Public title
Clinical effects of H12 hemodialyzer(AN69 membrane) in hemodialysis patients with uremic pruritus
Acronym
Clinical effects of AN69 membrane in hemodialysis patients with uremic pruritus
Scientific Title
Clinical effects of H12 hemodialyzer(AN69 membrane) in hemodialysis patients with uremic pruritus
Scientific Title:Acronym
Clinical effects of AN69 membrane in hemodialysis patients with uremic pruritus
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of AN69 having protein adsorption character on pruritus and pain,and examine the identification of the causative protein
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS score
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
H12 hemodialyzer(AN69)
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.hemodialysis patients with pururitus
2.The patient who was provided of the
informed consent
Key exclusion criteria
1. Age is under 20 years old
2. Pregnant women, the nursing women or
the pregnancy possibility
3. History of sensitivity or side effect
to blood purification and/or
extracorporeal circulation
4. Patients who participate in the
clinical trial of the medicine or
medical device or within three months
after the end of clinical trial
5. The case that the physician judged to
be inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichi Maruyama |
Organization
Nagoya University Hospital
Division name
Nephrology
Zip code
Address
65 Tsurumai-Cho,Showa-ku,Nagoya
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya University Hospital
Division name
Nephrology
Zip code
Address
65 Tsurumai-Cho,Showa-ku,Nagoya
TEL
052-741-2111
Homepage URL
Sponsor or person
Institute
Nagoya University Hospital
Division of Nephrology
Institute
Department
Personal name
Funding Source
Organization
Gambro
Organization
Division
Category of Funding Organization
Profit 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
| 2009 | Year | 08 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2009 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 02 | Day |
Last modified on
| 2009 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002481
| Research Plan | |
|---|---|
| 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 |
