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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036117
Receipt No. 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 2019/03/07

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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
Middle name
Last name YASUSHI OHASHI
Organization Toho University Sakura Medical Center
Division name Department of nephrology
Zip code
Address Shimoshizu 564-1, Sakura, Chiba
TEL 043-462-8811
Email ohashiy@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name institutional review board member
Organization Faculty of medicine, Toho University
Division name institutional review board
Zip code
Address Omori-nishi, Ota-ku, Tokyo
TEL 0337624151
Homepage URL
Email med.rinri@ext.toho-u.ac.jp

Sponsor
Institute Toho University
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2017 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 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
2019 Year 03 Month 07 Day
Last modified on
2019 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041135

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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