UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054335 |
|---|---|
| Receipt number | R000061959 |
| Scientific Title | Influence of nutrition-related indices on mortality in adult hemodialysis patients with malnutrition |
| Date of disclosure of the study information | 2024/05/08 |
| Last modified on | 2024/05/08 11:10:28 |
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Basic information
Public title
Influence of nutrition-related indices on mortality in adult hemodialysis patients with malnutrition
Acronym
Follow-up of Niigata KOME (Key Evaluation of Rice Proteins' Medical Benefits) Study 3
Scientific Title
Influence of nutrition-related indices on mortality in adult hemodialysis patients with malnutrition
Scientific Title:Acronym
Follow-up of Niigata KOME (Key Evaluation of Rice Proteins' Medical Benefits) Study 3
Region
| Japan |
Condition
Condition
Chronic kidney disease
(maintenance hemodialysis)
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the influence of nutrition-related indices on mortality in patients undergoing maintenance hemodialysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of survival curves according to nutrient-related indices at baseline in Niigata KOME Study 3, which investigated the effect of rice protein supplementation on nutritional and metabolic status in prevalent hemodialysis patients.
Key secondary outcomes
1) Comparison of cumulative hospitalization according to nutrient-related indices at baseline in Niigata KOME Study 3
2) Comparison of survival curves according to frequency of nutrition intake at baseline in Niigata KOME Study 3
3) Comparison of cumulative hospitalization events according to frequency of nutrition intake at baseline in Niigata KOME Study 3
4) Comparisons of nutrient-related indices and frequency of nutrient intake at baseline in Niigata KOME Study 3
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 in Niigata KOME Study 3
Adult prevalent hemodialysis patients who fulfill the following criteria will be included in the study:
1) Serum albumin concentration of< (or =) 3.8mg/dl
2) Body mass index of > (or =) 19 and <23 kg/m2
3) Dry weight 6 months ago is within 95-105% of current one
4) Normalized protein equivalent of nitrogen appearance (nPNA) of < 1.2g/kg/day
5) Those who have undergone maintenance hemodialysis for more than 2 years
6) Those who have given written informed consent on the use of their data for the study
Key exclusion criteria
Patients who participated in Niigata KOME Study 3 but declined to participate by opting out.
Adult prevalent hemodialysis patients who fulfill the following criteria will be excluded in the study:
1) Those with severe heart or liver disease
2) Those at perioperative stages, or those with severe infection or serious injury
3) Those with food allergy
4) Those who are considered not eligible for the study by attending doctors due to any medical reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Hosojima |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Clinical Nutrition Science, Kidney Research Center
Zip code
9518510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata City, Niigata
TEL
025-368-9312
hoso9582@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Michihiro |
| Middle name | |
| Last name | Hosojima |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Clinical Nutrition Science, Kidney Research Center
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata City, Niigata
TEL
025-368-9312
Homepage URL
hoso9582@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences, Kidney Research Center, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shinrakuen Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Niigata University
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata City, Niigata
Tel
025-227-2006
shomu@med.niigata-u.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
| 2024 | Year | 05 | Month | 08 | 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
50
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
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
| 2023 | Year | 10 | Month | 12 | Day |
Date trial data considered complete
| 2023 | Year | 10 | Month | 20 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 31 | Day |
Other
Other related information
A 10-year retrospective study of mortality up to 2023 among patients who participated in Niigata KOME Study 3 in 2013.
Management information
Registered date
| 2024 | Year | 05 | Month | 08 | Day |
Last modified on
| 2024 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061959
