UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002645 |
|---|---|
| Receipt number | 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 12:51:59 |
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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
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
mabe@med.nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Nerima Hikarigaoka Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001415
