UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060675 |
|---|---|
| Receipt number | R000069398 |
| Scientific Title | Association of Serum Zinc Levels with Renal Functional Stability and Long-term Prognosis: A Retrospective Cohort Study |
| Date of disclosure of the study information | 2026/02/16 |
| Last modified on | 2026/02/14 15:32:28 |
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Basic information
Public title
Study on the relationship between blood zinc levels and the maintenance of kidney function
Acronym
Zinc and Kidney Health Study
Scientific Title
Association of Serum Zinc Levels with Renal Functional Stability and Long-term Prognosis: A Retrospective Cohort Study
Scientific Title:Acronym
Zinc-Renal Stability Study
Region
| Japan |
Condition
Condition
Chronic Kidney Disease (CKD), Diabetic Kidney Disease (DKD), Hypertensive Nephrosclerosis
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to clarify the impact of serum zinc levels on the long-term decline rate (slope) of renal function (eGFR), its stability (coefficient of variation: CV), and renal hard outcomes. Specifically, we will verify the clinical validity of the pathomechanism "tubular cell repair failure due to zinc deficiency" suggested by our basic research. Furthermore, by comparing cohorts before and after the widespread use of SGLT2 inhibitors, we aim to evaluate whether serum zinc levels remain a useful biomarker for predicting renal functional stability under modern standard therapies.
Basic objectives2
Others
Basic objectives -Others
Retrospective observational study using existing data (Investigation of the clinical significance of serum zinc levels as a prognostic biomarker)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The long-term decline rate of estimated glomerular filtration rate (eGFR slope: mL/min/1.73m^2/year) calculated using a linear mixed model (LMM) during a follow-up period of up to 10 years (minimum 1.5 years) from the date of the first serum zinc measurement (baseline).
Key secondary outcomes
1. Coefficient of variation (CV) calculated from the residuals after removing the trend (decline) from the longitudinal eGFR trajectory during the follow-up period of up to 10 years.
2. Time to the first occurrence of a composite renal event (initiation of renal replacement therapy, sustained decline in eGFR of 40% or more from baseline, doubling of serum creatinine, or fatal/non-fatal cardiovascular events).
3. Time to the first hospitalization due to acute kidney injury (AKI).
4. Proportion of patients exhibiting a rapid decline in eGFR slope of -5 mL/min/1.73m^2/year or -3 mL/min/1.73m^2/year or steeper during the follow-up period.
5. Time to all-cause mortality.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria:
1. Serum zinc levels were measured at the Department of Endocrinology and Metabolism between January 1, 2015, and December 31, 2023.
2. Follow-up eGFR data are available for at least 1.5 years after the date of the first serum zinc measurement (baseline).
3. eGFR was measured at least three times after the baseline date.
Key exclusion criteria
Patients who meet any of the following criteria:
1. Receiving dialysis therapy (hemodialysis or peritoneal dialysis) or having undergone kidney transplantation at baseline.
2. Diagnosed with active malignancy at baseline (excluded from the primary analysis).
3. Received zinc supplementation (e.g., zinc acetate, polaprezinc) during the follow-up period (excluded from the primary analysis of natural clinical course).
Target sample size
2400
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Hayashi |
Organization
Shimane University Faculty of Medicine
Division name
Internal Medicine 1
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
+81-853-20-2183
yoshayashi@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Hayashi |
Organization
Shimane University Faculty of Medicine
Division name
Internal Medicine 1
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
+81-853-20-2183
Homepage URL
yoshayashi@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Secretariat of the Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1 Enya-cho, Izumo, Shimane
Tel
+81-853-20-2515
kenkyu@med.shimane-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
| 2026 | Year | 02 | 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
NO
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 10 | 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
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is a single-center, retrospective observational study using electronic medical records at Shimane University Hospital. We will include patients who had their serum zinc levels measured at the Department of Endocrinology and Metabolism. Using the date of the first zinc measurement as the baseline, we will collect data on patient characteristics, laboratory tests (blood and urine), and prescribed medications (e.g., SGLT2 inhibitors). We will retrospectively follow the longitudinal changes in eGFR (slope and coefficient of variation) and the incidence of composite renal events (e.g., initiation of renal replacement therapy, >=40% decline in eGFR) for up to 10 years to evaluate the impact of serum zinc levels on renal prognosis and functional stability.
Management information
Registered date
| 2026 | Year | 02 | Month | 14 | Day |
Last modified on
| 2026 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069398
