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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007969
Receipt No. R000009344
Scientific Title clinical efficacy of NV-21X (usefulness of material removal in the vicinity of 30,000 dalton molecular weight)
Date of disclosure of the study information 2012/05/21
Last modified on 2012/05/13

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Basic information
Public title clinical efficacy of NV-21X (usefulness of material removal in the vicinity of 30,000 dalton molecular weight)
Acronym clinical efficacy of NV-21X
Scientific Title clinical efficacy of NV-21X (usefulness of material removal in the vicinity of 30,000 dalton molecular weight)
Scientific Title:Acronym clinical efficacy of NV-21X
Region
Japan

Condition
Condition dialysis chronic renal failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to assess the effects of joint pain and improve symptoms of substance removal performance polysulfone membrane NV-21X type V
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A1-Mg,B2-Mg,albumin
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 clinical efficacy of NV-21X
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria long-time dialysis patients with joint pain in multiple places
Key exclusion criteria long-time dialysis patients without joint pain
Target sample size 1

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name seiya takamoto
Organization sanko clinics

Division name dialysis unit division engineer
Zip code
Address takatsuki,osaka,japan40-1gungeshin town
TEL 072-686-0880
Email

Public contact
Name of contact person
1st name
Middle name
Last name seiya takamoto
Organization sanko clinics
Division name dialysis unit division engineer
Zip code
Address takatsuki,osaka,japan40-1gungeshin town
TEL
Homepage URL
Email

Sponsor
Institute sanko clinics
Institute
Department

Funding Source
Organization no
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
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
2012 Year 05 Month 21 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
2012 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 05 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 05 Month 16 Day
Last modified on
2012 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009344

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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