UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008956 |
|---|---|
| Receipt number | R000010503 |
| Scientific Title | Evaluation for relationship between serum creatinine and volume fluid in patinets with Chronic Kidney Disase (pilot study) |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2013/03/21 09:06:41 |
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Basic information
Public title
Evaluation for relationship between serum creatinine and volume fluid in patinets with Chronic Kidney Disase (pilot study)
Acronym
Evaluation for volume fuluid in patinets with CKD
Scientific Title
Evaluation for relationship between serum creatinine and volume fluid in patinets with Chronic Kidney Disase (pilot study)
Scientific Title:Acronym
Evaluation for volume fuluid in patinets with CKD
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the relationship between serum creatinine and fluid retention
Basic objectives2
Others
Basic objectives -Others
Evaluation for renal function depending on serum cratinine chage
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Increase serum creatinine level with loss of fuluid retention
Key secondary outcomes
Loss of renal function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Diuretic drugs are used(for 3 months)
Interventions/Control_2
Diuretic drugs are not used(for 3 months)
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
CKD stage3-5 patients with over fluid retention
Key exclusion criteria
Nephrotic syndrome
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Masaki |
Organization
Hiroshima University Hospital
Division name
Department of Nephrology
Zip code
Address
1-2-3 Kasumi Minami-Ku Hiroshima City
TEL
082-257-1506
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Masaki |
Organization
Hiroshima University Hospital
Division name
Department of Nephrology
Zip code
Address
1-2-3 Kasumi Minami-Ku Hiroshima City
TEL
082-257-1506
Homepage URL
Sponsor or person
Institute
Department of Nephrology, Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
広島大学病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | 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 | 09 | Month | 21 | Day |
Last modified on
| 2013 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010503
