UMIN-CTR Clinical Trial

Basic information
Public title	A Study on Life Prediction by Combination of Geriatric Nutritional Risk Index and Modified Creatinine Index in Hemodialysis Patients
Acronym	A Study on Life Prediction by Combination of Geriatric Nutritional Risk Index and Modified Creatinine Index in Hemodialysis Patients
Scientific Title	A Study on Life Prediction by Combination of Geriatric Nutritional Risk Index and Modified Creatinine Index in Hemodialysis Patients
Scientific Title:Acronym	A Study on Life Prediction by Combination of Geriatric Nutritional Risk Index and Modified Creatinine Index in Hemodialysis Patients
Region	Japan

Condition
Condition	end-stage renal disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We hypothesize that the combination of GNRI and modified Cr index can predict life expectancy more sensitively, and the purpose of this study is to conduct a cohort study.
Basic objectives2	Others
Basic objectives -Others	We hypothesize that the combination of GNRI and modified Cr index can predict life expectancy more sensitively, and the purpose of this study is to conduct a cohort study.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	all-cause death after selection (February to September 2011) to January 2017
Key secondary outcomes	cardiovascular death, infectious disease death and cancer death after selection (February to September 2011) to January 2017

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent maintenance hemodialysis at our hospital and research collaborating institutions during the period of February to September 2011 Age 20 years or older
Key exclusion criteria	Under 20 years of age
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Tsutomu Middle name Last name Koike
Organization	University of Toyama
Division name	Department of Patient Safety and Healthcare Quality
Zip code	930-0194
Address	2630 Sugitani, Toyama 930-0194, Japan
TEL	076-434-7297
Email	tkoike@med.u-toyama.ac.jp

Public contact
Name of contact person	1st name Tsutomu Middle name Last name koike
Organization	University of Toyama
Division name	Department of Patient Safety and Healthcare Quality
Zip code	930-0194
Address	2630 Sugitani, Toyama 930-0194, Japan
TEL	076-434-7297
Homepage URL	https://toyama.bvits.com/rinri/publish.aspx
Email	tkoike@med.u-toyama.ac.jp

Sponsor
Institute	Second Department of Internal Medicine, University of Toyama
Institute
Department

Funding Source
Organization	Second Department of Internal Medicine, University of Toyama
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	University of Toyama
Address	2630 Sugitani, Toyama 930-0194, Japan
Tel	076-415-8857
Email	rinri@adm.u-toyama.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	2022 Year 01 Month 16 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	Suspended
Date of protocol fixation	2011 Year 02 Month 01 Day
Date of IRB	2021 Year 11 Month 29 Day
Anticipated trial start date	2011 Year 02 Month 01 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The prognostic study of 193 patients enrolled between February 2011 and September 2011 is ongoing.

Management information
Registered date	2022 Year 01 Month 16 Day
Last modified on	2022 Year 01 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053212

Research Plan
Registered date	File name
2022/01/16	研究計画書（GNRI， mCI）第3版.docx

Research case data specifications
Registered date	File name

Research case data
Registered date	File name
2022/01/16	repositry_GNRI.csv

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