UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044861 |
|---|---|
| Receipt number | R000051242 |
| Scientific Title | Nutrition and clinical outcomes in chronic kidney disease |
| Date of disclosure of the study information | 2021/07/20 |
| Last modified on | 2023/07/19 15:03:48 |
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Basic information
Public title
Nutrition and clinical outcomes in chronic kidney disease
Acronym
CKD and nutrition
Scientific Title
Nutrition and clinical outcomes in chronic kidney disease
Scientific Title:Acronym
CKD and nutrition
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the associations between nutrition and clinical outcomes
Basic objectives2
Others
Basic objectives -Others
Renal and life prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Doubling of serum creatinine level, reduction of eGFR, initiation of dialysis, mortality
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with chronic kidney disease aged from 18 to 85 y.o.
Key exclusion criteria
Patients aged under 18 y.o. and over 85 y.o.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Fukasawa |
Organization
Iwata city hospital
Division name
Renal division
Zip code
438-8550
Address
512-3 Ohkubo, Iwata
TEL
0538385000
hfukasawaucsd@gmail.com
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Fukasawa |
Organization
Iwata city hospital
Division name
Renal division
Zip code
438-8550
Address
512-3 Ohkubo, Iwata
TEL
0538385000
Homepage URL
hfukasawaucsd@gmail.com
Sponsor or person
Institute
Iwata city hospital
Institute
Department
Personal name
Funding Source
Organization
Iwata city 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
Iwata city hospital
Address
512-3 Ohkubo, Iwata
Tel
0538385000
hfukasawaucsd@gmail.com
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
| 2021 | Year | 07 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2021 | Year | 07 | Month | 14 | Day |
Last modified on
| 2023 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051242
