UMIN-CTR Clinical Trial

Basic information
Public title	Nutritional assessment of patients with chronic kidney disease
Acronym	Nutritional assessment of patients with chronic kidney disease
Scientific Title	Nutritional assessment of patients with chronic kidney disease
Scientific Title:Acronym	Nutritional assessment of patients with chronic kidney disease
Region	Japan

Condition
Condition	Chronic kidney disease(CKD)
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the nutritional status of CKD patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the nutritional status of CKD patients using Brief-type self-administered Diet History Questionnaire (BDHQ) and Bio-electrical Impedance Analysis (BIA)
Key secondary outcomes	To evaluate the exercise capacity of CKD patients by grip strength and chair-stand test

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	20 years-old <=
Age-upper limit	95 years-old >=
Gender	Male and Female
Key inclusion criteria	CKD patients with stage G3a or more
Key exclusion criteria	Patients complicated with serious diseases such as malignancy, heart failure (NYHA III degrees or more), and liver cirrhosis
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Michio Middle name Last name Kuwahara
Organization	Saitama Tsukinomori Clinic
Division name	Division of Nephrology
Zip code	339-0012
Address	366-1 Masunaga, Iwatsuki-ku, Saitama City, Saitama 339-0012, Japan
TEL	048-792-1811
Email	kuwahara@k-naika-cl.jp

Public contact
Name of contact person	1st name Megumi Middle name Last name Kobayashi
Organization	Saitama Tsukinomori Clinic
Division name	Division of Nutrition
Zip code	339-0012
Address	366-1 Masunaga, Iwatsuki-ku, Saitama City, Saitama 339-0012, Japan
TEL	048-792-1811
Homepage URL
Email	Kobayashi.megumi@k-naika-cl.jp

Sponsor
Institute	Saitama Tsukinomori Clinic
Institute
Department

Funding Source
Organization	Saitama Tsukinomori Clinic
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 ethics committee of Saitama Tsukinomori Clinic
Address	366-1 Masunaga, Iwatsuki-ku, Saitama City, Saitama 339-0012, Japan
Tel	0487921811
Email	hayama@k-naika-cl.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	2017 Year 11 Month 23 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	2015 Year 04 Month 01 Day
Date of IRB	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2021 Year 07 Month 31 Day
Date of closure to data entry	2021 Year 09 Month 30 Day
Date trial data considered complete	2021 Year 09 Month 30 Day
Date analysis concluded	2021 Year 09 Month 30 Day

Other
Other related information	We have continued to evaluate the nutrition of patients with chronic kidney disease according to the protocol of this study. However, because the dietitian in charge retired, we could not continue the research and had to stop.

Management information
Registered date	2017 Year 11 Month 23 Day
Last modified on	2021 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034356