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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031432
Receipt No. 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

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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
Email 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
Email t-nakao@tokyo-med.ac.jp

Sponsor
Institute Kisen KD Clinic
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035886

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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