UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045895 |
|---|---|
| Receipt number | R000052363 |
| Scientific Title | A clinical significance of blood ketone levels in CKD patients : a prospective observational study |
| Date of disclosure of the study information | 2021/11/11 |
| Last modified on | 2021/10/28 11:11:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ishiit@yamanashi.ac.jp
Sponsor or person
Institute
Department of Nephrology, University of Yamanashi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052363
