UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045908 |
|---|---|
| Receipt number | R000052395 |
| Scientific Title | A retrospective study of the association between baseline urinary megalin levels and subsequent estimated glomerular filtration rate in patients with type 2 diabetes or chronic kidney disease |
| Date of disclosure of the study information | 2021/10/29 |
| Last modified on | 2024/04/30 15:44:24 |
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Basic information
Public title
Urinary megalin excretion as a predictor of kidney outcome in patients with type 2 diabetes or chronic kidney disease
Acronym
Not applicable
Scientific Title
A retrospective study of the association between baseline urinary megalin levels and subsequent estimated glomerular filtration rate in patients with type 2 diabetes or chronic kidney disease
Scientific Title:Acronym
Not applicable
Region
| Japan |
Condition
Condition
Type 2 diabetes
Chronic kidney disease
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate urinary megalin excretion as a predictor of kidney outcome in patients with type 2 diabetes or chronic kidney disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Associations of urinary megalin excretion and megalin ligand molecules (e.g., alfa 1-microglobulin, beta 2-microglobulin) with changes in estimated glomerular filtration rate, urinary albumin/creatinine ratio, and urinary protein levels
Key secondary outcomes
1. Changes in body weight, blood pressure, and HbA1c during the observation period
2. Changes in other biomarkers (urinary podocalyxin, etc.) during the observation period
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
1. Type 2 diabetes or chronic kidney disease
2. Urine specimens stored at the Division of Clinical Nephrology and Rheumatology or Department of Applied Molecular Medicine, Niigata University, with informed consent to participate in this clinical study, which was approved by the Ethics Committee of Niigata University (approval no. 191 in 2003)
Key exclusion criteria
1. Severe active infection or severe trauma
2. Pregnancy
3. Deemed ineligible for this study by attending doctors for any medical reason
4. Declining analysis of their urine samples
5. Short observation period (less than 6 months)
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | Saito |
Organization
Niigata University Graduate School
of Medical and Dental Science
Division name
Department of Applied Molecular Medicine, Kidney Research Center
Zip code
951-8510
Address
1-757 Asahimachi Dori, Chuo-ku, Niigata City
TEL
025-227-0915
akisaito@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 Science
Division name
Department of Clinical Nutrition Science, Kidney Research Center
Zip code
951-8510
Address
1-757 Asahimachi Dori, Chu-o-ku Niigata City
TEL
025-368-9312
Homepage URL
hoso9582@med.niigata-u.ac.jp
Sponsor or person
Institute
Department of Applied Molecular Medicine, Kidney Research Center, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science KAKENHI
The Japan Agency for Medical Research and Development
The Japan Research Foundation for Clinical Pharmacology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Niigata University School of Medicine
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata City, Niigata 951-8510 Japan
Tel
025-227-2006
ethics@adm.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
新潟大学医歯学総合病院/Niigata University Medical & Dental Hospital
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36228564/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36228564/
Number of participants that the trial has enrolled
191
Results
We retrospectively analyzed 188 patients with type 2 diabetes. The eGFR slopes of the higher A-megalin/Cr and higher C-megalin/Cr groups were - 0.904 and -0.749 ml/min/1.73 m2/year steeper than those of the lower groups, respectively. Moreover, the eGFR slope was -1.888 ml/min/1.73 m2/year steeper in the group with both higher A- and higher C-megalin/Cr than in the other group.
Results date posted
| 2024 | Year | 04 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 09 | Month | 24 | Day |
Baseline Characteristics
This retrospective study involved 191 Japanese adults (aged 20 years or older) with type 2 diabetes who were outpatients at the Division of Clinical Nephrology and Rheumatology, Niigata University Medical and Dental Hospital. Patients with severe active infectious disease, severe trauma, or pregnancy were excluded. Patients in the perioperative period or with a short observation period (<6 months) were also excluded.
Participant flow
Standard clinical examinations and biochemical tests were performed regularly in the patients, and urine samples were stocked annually at -80 during the follow-up period. The oldest stocked urine sample of all participants collected during this period was defined as the baseline sample. We measured urine A-megalin, C-megalin, alpha1-MG, beta2-MG, NAG, albumin, and creatinine (Cr)levels. Serum Cr, blood urea nitrogen, uric acid, and hemoglobin A1c of blood samples collected on the same date were measured as baseline data. The eGFR slope was calculated using eGFR values derived from serum Cr levels, which were recorded about once a year in the electronic medical records and collected retrospectively.
Adverse events
Not applicable
Outcome measures
We retrospectively analyzed 188 patients with type 2 diabetes. The eGFR slopes of the higher A-megalin/Cr and higher C-megalin/Cr groups were - 0.904 and -0.749 ml/min/1.73 m2/year steeper than those of the lower groups, respectively. Moreover, the eGFR slope was -1.888 ml/min/1.73 m2/year steeper in the group with both higher A- and higher C-megalin/Cr than in the other group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2007 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
not applicable
Management information
Registered date
| 2021 | Year | 10 | Month | 28 | Day |
Last modified on
| 2024 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052395
