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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025141
Receipt No. R000028913
Scientific Title The effect of protein restricted diet on patients with chronic kidney disease on suppression of renal function reduction
Date of disclosure of the study information 2016/12/06
Last modified on 2020/06/08

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Basic information
Public title The effect of protein restricted diet on patients with chronic kidney disease on suppression of renal function reduction
Acronym The effect of protein restricted diet on patients with chronic kidney disease on suppression of renal function reduction
Scientific Title The effect of protein restricted diet on patients with chronic kidney disease on suppression of renal function reduction
Scientific Title:Acronym The effect of protein restricted diet on patients with chronic kidney disease on suppression of renal function reduction
Region
Japan

Condition
Condition non-dialysis chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine adequate protein intake in chronic kidney disease (CKD).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes nutrient ingestion amount
(at registration, 3 months, 6 months, 12 months, 24 months)
Key secondary outcomes Serum creatinine
eGFR
BUN
Hb

Base
Study type Others,meta-analysis etc

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 1)education by a registered dietitian
2)obtain written informed consent
3)eGFR<45ml/min/1.73mm2
(CKD stage 3a, 3b, 4 and 5)
4)non-peritoneal dialysis and non-hemodialysis
Key exclusion criteria patients who are administering corticosteroids
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Yoshihiko
Middle name
Last name Kanno
Organization Tokyo Medical University
Division name Division of Nephrology
Zip code 160-0023
Address 6-7-1 Nishishinjyuku,Shinjyuku-ku,Tokyo
TEL 03-3342-6111
Email kannoyh@tokyo-med.ac.jp

Public contact
Name of contact person
1st name Yukie
Middle name
Last name Kitajima
Organization Tokyo Healthcare University
Division name Division of Medical Nutrition
Zip code 154-8568
Address 3-11-3 Setagaya, Setagaya-ku, Tokyo
TEL 03-5799-3711
Homepage URL
Email y-kitajima@thcu.ac.jp

Sponsor
Institute The Japanese Society of Renal Nutrition and Metabolism
Institute
Department

Funding Source
Organization The Japanese Society of Renal Nutrition and Metabolism
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 The Japanese Society of Renal Nutrition and Metabolism
Address 4-1-5-6, Hongou, Bunkyo-ku, Tokyo
Tel 03-6801-8084
Email kannoyh@tokyo-med.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
2016 Year 12 Month 06 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 54
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
2016 Year 06 Month 29 Day
Date of IRB
2016 Year 06 Month 29 Day
Anticipated trial start date
2016 Year 12 Month 15 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
2021 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information There is no other related information

Management information
Registered date
2016 Year 12 Month 05 Day
Last modified on
2020 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028913

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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