UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061619 |
|---|---|
| Receipt number | R000070498 |
| Scientific Title | A prospective study evaluating changes in urinary albumin before and after pharmacotherapy in obese patients with chronic kidney disease (CKD) |
| Date of disclosure of the study information | 2026/05/18 |
| Last modified on | 2026/05/19 14:41:27 |
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Basic information
Public title
A study to evaluate the effects of obesity medications on kidney function in obese patients with chronic kidney disease
Acronym
Kidney Study for Obese Patients with CKD
Scientific Title
A prospective study evaluating changes in urinary albumin before and after pharmacotherapy in obese patients with chronic kidney disease (CKD)
Scientific Title:Acronym
Prospective evaluation of urinary albumin changes by GLP-1/GIP receptor agonists in obese patients with CKD
Region
| Japan |
Condition
Condition
Obesity complicated with Chronic Kidney Disease (CKD)
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the changes in the urinary albumin-to-creatinine ratio (UACR) from baseline to 52 weeks after the initiation of GLP-1 or GLP-1/GIP receptor agonists, and to clarify their impact on renal microvascular damage in obese patients with chronic kidney disease (CKD).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in urinary albumin-to-creatinine ratio (UACR) from baseline to 52 weeks after the initiation of treatment
Key secondary outcomes
1. Changes in physical indices (body weight, BMI) from baseline to 52 weeks.
2. Changes in renal function indices (eGFR, etc.) from baseline to 52 weeks.
3. Changes in metabolic/organ function indices and blood pressure (HbA1c, total cholesterol, LDL-C, triglycerides, uric acid, AST, ALT, gamma-GTP, blood pressure) from baseline to 52 weeks.
4. Transitions in urinary albumin-to-creatinine ratio (UACR) at baseline, 24 weeks, and 52 weeks after the start of treatment.
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
Patients who meet all of the following criteria:
1.Patients diagnosed with obesity who will start treatment with a GLP-1RA or GIP/GLP-1RA based on the physician's judgment.
2.Patients with chronic kidney disease (CKD) (defined as an albuminuric state with a urinary albumin-to-creatinine ratio (UACR) of >= 30 mg/gCr, or an estimated glomerular filtration rate (eGFR) of < 60 mL/min/1.73m2, or both).
3.Age 18 years or older.
4.Individuals who have received an explanation about participating in this study and provided written consent.
Key exclusion criteria
Individuals falling under any of the following are excluded:
1.Pregnant or breastfeeding women.
2.Patients deemed inappropriate by the attending physician due to their medical condition, treatment status, or other reasons.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Harada |
Organization
Kagawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-891-2230
muraeri0217@gmail.com
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Harada |
Organization
Kagawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-891-2230
Homepage URL
muraeri0217@gmail.com
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Eri Harada
Funding Source
Organization
Kagawa University
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
Kagawa University Faculty of Medicine Ethics Committee
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
Tel
087-898-5111
kenkyushien-m@kagawa-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 | 05 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study targeting patients receiving standard-of-care treatment for obesity, and participation in the study will not alter the medical treatment provided. The study is conducted using research funds from the Department of Endocrinology and Metabolism, without funding or benefits from corporate entities, and the researchers have no conflicts of interest to disclose.
Management information
Registered date
| 2026 | Year | 05 | Month | 18 | Day |
Last modified on
| 2026 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070498
