UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002223 |
|---|---|
| Receipt number | R000002730 |
| Scientific Title | Clinical research for appropriate total parenteral nutrition in patients with chronic kidney disease at stages 3, 4 and 5 |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2012/07/18 14:26:49 |
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Basic information
Public title
Clinical research for appropriate total parenteral nutrition in patients with chronic kidney disease at stages 3, 4 and 5
Acronym
Appropriate total parenteral nutrition in patients with chronic kidney disease
Scientific Title
Clinical research for appropriate total parenteral nutrition in patients with chronic kidney disease at stages 3, 4 and 5
Scientific Title:Acronym
Appropriate total parenteral nutrition in patients with chronic kidney disease
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of safty for total pareteral nutrition in patients with chronic kidney disease
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Concentration of ingredients in total parenteral nutrition
Key secondary outcomes
None
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Total pareteral nutrition
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Chronic kidney disease at stages 3, 4, and 5
2) Indication for total pareteral nutrition
Key exclusion criteria
1) Severe liver function
2) Severe coagulation disturbance
3) Contraindication for administration of ingredients of total pareteral nutrition
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Okada |
Organization
Nihon University School of Medicine, Itabasi Hospital
Division name
Department of Nephrology, Hypertension and Endocrinology
Zip code
Address
30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nihon University School of Medicine, Itabasi Hospital
Division name
Department of Nephrology, Hypertension and Endocrinology
Zip code
Address
TEL
03-3972-8111
Homepage URL
Sponsor or person
Institute
Department of Nephrology, Hypertension and Endocrinology, Nihon University School of Medicine, Itabasi Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Nephrology, Hypertension and Endocrinology, Nihon University School of Medicine, Itabasi Hospital
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
| 2015 | Year | 01 | 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
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 18 | Day |
Last modified on
| 2012 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002730
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
