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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002645
Receipt No. R000001415
Scientific Title Plasma insulin and C-peptide concentrations in diabetic patients undergoing hemodialysis: Comparison with 5 types of high-flux dialyzer membranes
Date of disclosure of the study information 2009/10/21
Last modified on 2009/10/19

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Basic information
Public title Plasma insulin and C-peptide concentrations in diabetic patients undergoing hemodialysis: Comparison with 5 types of high-flux dialyzer membranes
Acronym IRI and CPR removal by dialyzers
Scientific Title Plasma insulin and C-peptide concentrations in diabetic patients undergoing hemodialysis: Comparison with 5 types of high-flux dialyzer membranes
Scientific Title:Acronym IRI and CPR removal by dialyzers
Region
Japan

Condition
Condition hemodialysis patients with diabetes
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the changes in the plasma immunoreactive insulin (IRI) and connecting peptide immunoreactivity (CPR) concentrations resulting from HD treatment in diabetic patients, performed using 5 types of high-flux dialyzer membranes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of the changes in the plasma IRI and CPR concentrations resulting from using 5 types of dialyzer membranes.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Using PS membrane
Interventions/Control_2 Using PES membrane
Interventions/Control_3 Using CTA membrane
Interventions/Control_4 Using PMMA membrane
Interventions/Control_5 Using PEPA membrane
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
80 years-old >
Gender Male and Female
Key inclusion criteria Stable hemodialysis patients who are treated three times/week for 4 hours.
Key exclusion criteria 1)Patients with unstable glycemic control.2)Patients with severe
infectious disease, malignancy, and who were being treated with steroids. 3) Patients who are not able to change the dialyzer due to allergy.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Abe
Organization Nihon University School of Medicine
Division name Nephrology, Hypertension, and Endocrinology
Zip code
Address 30-1, Oyaguchi-kamimachi,Itabashi, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Abe
Organization Nihon University School of Medicine
Division name Nephrology, Hypertenson, and Endoclinology
Zip code
Address
TEL
Homepage URL
Email mabe@med.nihon-u.ac.jp

Sponsor
Institute Nihon University Nerima Hikarigaoka Hospital
Institute
Department

Funding Source
Organization Nihon University School of Medicine, Deportment of Medicine, Division of Nephrology, Hypertension, and Endocrinology
Organization
Division
Category of Funding Organization Self funding
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
2009 Year 10 Month 21 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2008 Year 04 Month 08 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2008 Year 05 Month 01 Day
Date of closure to data entry
2008 Year 05 Month 01 Day
Date trial data considered complete
2008 Year 05 Month 01 Day
Date analysis concluded
2008 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 19 Day
Last modified on
2009 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001415

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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