UMIN-CTR Clinical Trial

Basic information
Public title	A clinical significance of blood ketone levels in CKD patients : a prospective observational study
Acronym	A evaluation of the clinical significance of blood ketone levels in CKD patients
Scientific Title	A clinical significance of blood ketone levels in CKD patients : a prospective observational study
Scientific Title:Acronym	A evaluation of the clinical significance of blood ketone levels in CKD patients
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study was to investigate the relationship between blood ketone levels and renal prognosis in patients with chronic kidney disease
Basic objectives2	Others
Basic objectives -Others	Investigation of clinical factors affecting blood ketone levels in CKD patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	decline in eGFR
Key secondary outcomes	Progression to end-stage kidney disease Progression to next stage of eGFR classification eGFR slope Cardiovascular disease event All-cause mortality Sarcopenia Falling and fructure

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	CKD patients attending the study facilities
Key exclusion criteria	1)End-stage kidney disease 2)Acute kidney injury 3)Type 1 diabetes or insulin-dependent dia betes 4)Diabetic ketoacidosis or hyperglycemic h yperosmolar syndrome 5)Liver failure 6)Malignancy 7)Active infectious disease 8)Surgery within 3 months prior to study enrollment (excluding minor surgery) 9)Other cases deemed inappropriate by the physician
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Toshihisa Middle name Last name Ishii
Organization	University of Yamanashi Hospital
Division name	Department of Nephrology
Zip code	409-3898
Address	1110 Shimokato, Chuo city, Yamanashi Prefecture
TEL	055-273-9602
Email	ishiit@yamanashi.ac.jp

Public contact
Name of contact person	1st name Toshihisa Middle name Last name Ishii
Organization	University of Yamanashi Hospital
Division name	Department of Nephrology
Zip code	409-3898
Address	1110 Shimokato, Chuo city, Yamanashi Prefecture
TEL	055-273-9602
Homepage URL
Email	ishiit@yamanashi.ac.jp

Sponsor
Institute	Department of Nephrology, University of Yamanashi Hospital
Institute
Department

Funding Source
Organization	Department of Nephrology, University of Yamanashi Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Haraguchi Internal Medicine-Kidney Clinic Alpus kidney Clinic Sakurabayashi kidney-Internal Medicine Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of Yamanashi Hospital
Address	1110 Shimokato, Chuo city, Yamanashi Prefecture
Tel	055-273-9602
Email	ishiit@yamanashi.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	山梨大学医学部附属病院（山梨県）

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 11 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	Preinitiation
Date of protocol fixation	2021 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date	2022 Year 01 Month 01 Day
Last follow-up date	2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	All registered patients are prospectively followed up every 3 months in the hospital or clinic visit. Blood ketone levels are measured at study entry.

Management information
Registered date	2021 Year 10 Month 28 Day
Last modified on	2021 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052363