UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036117 |
|---|---|
| Receipt number | R000041135 |
| Scientific Title | Dietary Approaches based on nutrition-related risk to improve Mortality, Nutritional status, and Disease Progression in Patients with Chronic Kidney Disease (DIAMOND study): a prospective cohort study |
| Date of disclosure of the study information | 2019/03/08 |
| Last modified on | 2022/09/08 16:39:29 |
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Basic information
Public title
Dietary Approaches based on nutrition-related risk to improve Mortality, Nutritional status, and Disease Progression in Patients with Chronic Kidney Disease (DIAMOND study): a prospective cohort study
Acronym
DIAMOND study
Scientific Title
Dietary Approaches based on nutrition-related risk to improve Mortality, Nutritional status, and Disease Progression in Patients with Chronic Kidney Disease (DIAMOND study): a prospective cohort study
Scientific Title:Acronym
DIAMOND study
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Does dietary Approaches based on nutrition-related risk improve mortality, nutritional status, and disease progression in patients with chronic kidney disease ?
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A decline of 50% or more from baseline glomerular filtration rate or initiation of renal replacement therapy
Key secondary outcomes
Death or any of cardiac vascular events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Standard dietary approach of protein-restricted diet
Interventions/Control_2
Dietary Approaches based on nutrition-related risk
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with chronic kidney disease who need any dietary approach of protein-restricted diet
Key exclusion criteria
1) Unable to obtain informed consent
2) Be under age
3) Current treatment for psychosis
4) Advanced dementia
5) Current immunosuppressive therapy for nephritis
6) History of any cardiovascular diseases within 6 months
7) eGFR of less than 10 mL/min/1.73m2
8) Current pregnancy
Target sample size
384
Research contact person
Name of lead principal investigator
| 1st name | YASUSHI |
| Middle name | |
| Last name | OHASHI |
Organization
Toho University Sakura Medical Center
Division name
Department of nephrology
Zip code
285-8741
Address
Shimoshizu 564-1, Sakura, Chiba
TEL
0434628811
ohashiy@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | member |
| Middle name | |
| Last name | institutional review board |
Organization
Faculty of medicine, Toho University
Division name
institutional review board
Zip code
285-8741
Address
Shimoshizu 564-1, Sakura, Chiba
TEL
0434628811
Homepage URL
ohashiy@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Toho University
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
Toho University Sakura Medical Center
Address
Shimoshizu 564-1, Sakura, Chiba
Tel
0434628811
ohashiy@med.toho-u.ac.jp
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
| 2019 | Year | 03 | Month | 08 | 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
| 2017 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 07 | Day |
Last modified on
| 2022 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041135
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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