UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001702 |
|---|---|
| Receipt number | R000002050 |
| Scientific Title | Simplified measurement of inulin clearance by the bolus-injection of inulin |
| Date of disclosure of the study information | 2009/02/15 |
| Last modified on | 2016/02/12 13:00:15 |
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Basic information
Public title
Simplified measurement of inulin clearance by the bolus-injection of inulin
Acronym
Inulin clearance by the bolus-injection method
Scientific Title
Simplified measurement of inulin clearance by the bolus-injection of inulin
Scientific Title:Acronym
Inulin clearance by the bolus-injection method
Region
| Japan |
Condition
Condition
Chronic kidney diseases (CKD), diabetes mellitus (DM)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of more simplified measurement of glomerular filtration rate by the bolus-injection of inulin
Basic objectives2
Others
Basic objectives -Others
Utility of the measurement
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy as the measurement of glomerular filtration method
Key secondary outcomes
Complication in performing the measurement
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients hospitalized in the Nephrology Division whom the attending doctor admits eligible for the measurement.
Key exclusion criteria
Patients whom the attending doctor admits ineligible for the measurement
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Maeda |
Organization
JA Toride Medical Center
Division name
Nephrology
Zip code
Address
2-1-1 Hongoh, Toride, Ibaraki
TEL
0297-74-5551
yoshimaeda43@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Maeda |
Organization
JA Toride Medical Center
Division name
Nephrology
Zip code
Address
2-1-1 Hongoh, Toride, Ibaraki
TEL
0297-74-5551
Homepage URL
yoshimaeda43@yahoo.co.jp
Sponsor or person
Institute
JA Toride Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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 | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
At present, fifteen patients have been enrolled in this study. A few candidate parameters of inulin-pharmacokinetics have been analyzed for selecting the most suitable index for glomerular filtration rate.
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
Main results already published
Date of protocol fixation
| 2009 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 10 | Month | 01 | Day |
Other
Other related information
The measurement of inulin clearance by the pharmacokinetics of serum and urinary inulin concentration
Management information
Registered date
| 2009 | Year | 02 | Month | 12 | Day |
Last modified on
| 2016 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002050
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
