UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062937 |
|---|---|
| Receipt number | R000072019 |
| Scientific Title | A Prospective Observational Study of the Association Between Longitudinal Changes in Serum Soluble Klotho Levels and Dietary Intake Patterns in Patients Undergoing Living Donor Kidney Transplantation |
| Date of disclosure of the study information | 2026/09/15 |
| Last modified on | 2026/09/15 20:58:34 |
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Basic information
Public title
Study of Changes in Serum Soluble Klotho Levels and Dietary Intake Patterns in Patients Undergoing Living Donor Kidney Transplantation
Acronym
K-MEAL Study (Klotho and Meal-based dietary Evaluation Across Living donor kidney transplantation)
Scientific Title
A Prospective Observational Study of the Association Between Longitudinal Changes in Serum Soluble Klotho Levels and Dietary Intake Patterns in Patients Undergoing Living Donor Kidney Transplantation
Scientific Title:Acronym
K-MEAL Prospective Observational Study
Region
| Japan |
Condition
Condition
Living Donor Kidney Transplantation
Classification by specialty
| Nephrology | Surgery in general | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to prospectively characterize longitudinal changes in serum soluble Klotho levels measured before living donor kidney transplantation and at one week and six months after transplantation, and to examine the associations between these changes and dietary intake patterns assessed using the Meal-based Diet History Questionnaire (MDHQ), as well as nutritional status.
Basic objectives2
Others
Basic objectives -Others
Assessment of the association between longitudinal changes in serum soluble Klotho levels and dietary intake patterns
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Longitudinal changes in serum soluble Klotho (sKl) levels before, one week after, and six months after living donor kidney transplantation
Key secondary outcomes
1) Associations of serum sKl levels and changes in serum sKl levels with kidney function parameters, including serum creatinine, eGFR, changes in eGFR, blood urea nitrogen, urinary protein excretion, and urinary albumin excretion
2) Associations of serum sKl levels and changes in serum sKl levels with markers of mineral metabolism, including serum phosphorus, magnesium, calcium, alkaline phosphatase, intact parathyroid hormone, 25-hydroxyvitamin D, and markers of tubular phosphate reabsorption
3) Associations of serum sKl levels and changes in serum sKl levels with energy, nutrient, and food group intakes assessed using the MDHQ
4) Associations of serum sKl levels and changes in serum sKl levels with diet quality indices, including the HEI-2015, NRF9.3, PRAL, and NEAP
5) Associations of serum sKl levels and changes in serum sKl levels with indicators of nutritional status, including GLIM criteria, PNI, CONUT, MDS, serum albumin, body weight, BMI, SMI, LAMA, IMAT, visceral fat, and subcutaneous fat
6) Associations of serum sKl levels and changes in serum sKl levels with clinical outcomes after kidney transplantation, including DGF, rejection, rehospitalization, and recovery of kidney graft function
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 18 years or older who are scheduled to undergo living donor kidney transplantation at our hospital
2) Patients who provide written informed consent to participate in this study
Key exclusion criteria
1) Patients scheduled to undergo simultaneous multiple-organ transplantation
2) Patients undergoing deceased donor kidney transplantation
3) Patients who are considered unable to complete the Meal-based Diet History Questionnaire (MDHQ) because of cognitive impairment or other reasons
4) Patients who develop serious perioperative complications and are considered unable to continue participating in the study
5) Patients considered unsuitable for participation in this study by the principal investigator or other investigators
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tetsuhiko |
| Middle name | |
| Last name | Sato |
Organization
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Division name
Division of Strategic Outreach Medicine
Zip code
466-8650
Address
2-9 Myoken-cho, Showa-ku, Nagoya, Aichi 466-8650, Japan
TEL
052-832-1121
tetssato@nagoya2.jrc.or.jp
Public contact
Name of contact person
| 1st name | Keigo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Division name
Department of Nutrition
Zip code
466-8650
Address
2-9 Myoken-cho, Showa-ku, Nagoya, Aichi 466-8650, Japan
TEL
052-832-1121
Homepage URL
hatake@nagoya2.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Address
2-9 Myoken-cho, Showa-ku, Nagoya, Aichi 466-8650, Japan
Tel
052-832-1121
IRB-JIMU@nagoya2.jrc.or.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
| 2026 | Year | 09 | Month | 15 | 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
| 2026 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2028 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Factors examined for association include dietary intake and diet quality assessed using the Meal-based Diet History Questionnaire (MDHQ), kidney function, mineral metabolism, nutritional status, medication use, and the clinical course after kidney transplantation. The outcomes are serum soluble Klotho (sKl) levels before, one week after, and six months after living donor kidney transplantation and changes in sKl levels. Associations between these factors and the outcomes will be evaluated.
Management information
Registered date
| 2026 | Year | 09 | Month | 15 | Day |
Last modified on
| 2026 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072019
