UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009882 |
|---|---|
| Receipt number | R000011561 |
| Scientific Title | The investigation of the clinical factor against renal detorioration in our predialytic patients with chronic kidney disease |
| Date of disclosure of the study information | 2013/01/28 |
| Last modified on | 2013/01/28 14:08:21 |
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Basic information
Public title
The investigation of the clinical factor against renal detorioration in our predialytic patients with chronic kidney disease
Acronym
The supression factor against CRF in predialytic patients with CKD
Scientific Title
The investigation of the clinical factor against renal detorioration in our predialytic patients with chronic kidney disease
Scientific Title:Acronym
The supression factor against CRF in predialytic patients with CKD
Region
| Japan |
Condition
Condition
our predialytic patients with CKD treated by our predialytic treatment protocol in Aso-Iizuka Hospital (ex:antihypertensive therapy, low protein diet, sodium restriction)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
understanding of real our predialytic treatment in our hospital, the prognosis of our patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the induction of dialysis, death, CVD onset,
Key secondary outcomes
the duration and frequency of admission, ADL, renal dysfunction rate, the differenses between DM and non-DM, life survival, the frequency of infection
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food | Device,equipment |
Interventions/Control_1
nutrition control
Interventions/Control_2
control of BP
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
performed or not, predialytic protocal treatment in Aso-Iizuka Hospital
Key exclusion criteria
non-compliance or drop-out cases
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhito Takeda |
Organization
Aso-Iizuka Hospital
Division name
Department of Nephrology
Zip code
Address
3-83 Yoshio-Cho, Iizuka City
TEL
0948-22-3800
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhito Takeda |
Organization
Aso-Iizuka Hospital
Division name
Department of Nephrology
Zip code
Address
TEL
0948-22-3800
Homepage URL
Sponsor or person
Institute
Aso-Iizuka Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2013 | Year | 01 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2001 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 04 | Month | 10 | 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
| 2013 | Year | 01 | Month | 28 | Day |
Last modified on
| 2013 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011561
