UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031432 |
|---|---|
| Receipt number | R000035886 |
| Scientific Title | Effect of very low-protein diet on postponing the initiation of renal replacement therapy in patients with chronic renal failure |
| Date of disclosure of the study information | 2018/02/22 |
| Last modified on | 2018/02/22 20:18:01 |
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Basic information
Public title
Effect of very low-protein diet on postponing the initiation of renal replacement therapy in patients with chronic renal failure
Acronym
Very low-protein diet for chronic renal failure
Scientific Title
Effect of very low-protein diet on postponing the initiation of renal replacement therapy in patients with chronic renal failure
Scientific Title:Acronym
Very low-protein diet for chronic renal failure
Region
| Japan |
Condition
Condition
chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study whether very low-protein diet for the patients with chronic renal failure can postpone the initiation of renal replacement therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
initiation of renal replacement therapy
Key secondary outcomes
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
CKD stage 4 and 5
Key exclusion criteria
Disabilities of oral dietary intake.
Insufficient energy intake.
Malignancies.
Infalamation.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhisa Otanai |
Organization
Kisen KD Clinic
Division name
Department of Nephrology
Zip code
Address
Zenmyoji 358-1, Wakayama city, Japan
TEL
81-073-454-5515
otani@hakubunnkai.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Nakao |
Organization
Organization for Kidney Metabolic Disease
Division name
Department of Nephrology
Zip code
Address
Kubo Build. 3F, Yoyogi 2-9-2, Sibuya ward, Tokyo, Japan
TEL
81-3-3376-0191
Homepage URL
t-nakao@tokyo-med.ac.jp
Sponsor or person
Institute
Kisen KD Clinic
Institute
Department
Personal name
Funding Source
Organization
Self-sourcing
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
| 2018 | Year | 02 | Month | 22 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 02 | Month | 22 | Day |
Last modified on
| 2018 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035886
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
