UMIN-CTR Clinical Trial

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
Email	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
Email	ohashiy@med.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	Toho University Sakura Medical Center
Address	Shimoshizu 564-1, Sakura, Chiba
Tel	0434628811
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041135