UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058358 |
|---|---|
| Receipt number | R000066715 |
| Scientific Title | Investigation of the Longitudinal Effects of Shichimotsukokato on Renal Function in Patients with Chronic Kidney Disease |
| Date of disclosure of the study information | 2025/07/03 |
| Last modified on | 2025/07/03 14:38:57 |
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Basic information
Public title
Investigation of the Longitudinal Effects of Shichimotsukokato on Renal Function in Patients with Chronic Kidney Disease
Acronym
Investigation of the Longitudinal Effects of Shichimotsukokato on Renal Function in Patients with Chronic Kidney Disease
Scientific Title
Investigation of the Longitudinal Effects of Shichimotsukokato on Renal Function in Patients with Chronic Kidney Disease
Scientific Title:Acronym
Investigation of the Longitudinal Effects of Shichimotsukokato on Renal Function in Patients with Chronic Kidney Disease
Region
| Japan |
Condition
Condition
Chronic Kidney Disease (CKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the longitudinal effects of Shichimotsukokato on renal function in patients with CKD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
eGFR slope before and after one year of Shichimotsukokato administration
Key secondary outcomes
Change in SBP, DBP, and urinary protein before and after one year treatment
Adverse events
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. Age=>18 years
2. History of medical visits to the participating institutions between April 2019 and May 2025
3. Diagnosed with CKD according to the Japanese Guideline for CKD 2023
4. Continuously administered Shichimotsukokato for at least one year
5. Availability of blood test data, including eGFR at three time points (one year before initiation, at initiation, and one year after initiation of Shichimotsukokato)
Key exclusion criteria
Individuals who refuse to participate in this study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kazushi |
| Middle name | |
| Last name | Uneda |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Department of Kampo Medicine
Zip code
969-3492
Address
21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima
TEL
+81-242-75-2100
uneda@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kazushi |
| Middle name | |
| Last name | Uneda |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Department of Kampo Medicine
Zip code
969-3492
Address
21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima
TEL
+81-242-75-2100
Homepage URL
https://www.fmu.ac.jp/amc/index.html
uneda@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Kazushi Uneda
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tenjinbashi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Kampo Medicine, Aizu Medical Center, Fukushima Medical University
Address
21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima 969-3492, Japan
Tel
0242-75-2100
uneda@fmu.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
| 2025 | Year | 07 | Month | 03 | 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
| 2025 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis period: June 2025 to March 2026
Management information
Registered date
| 2025 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066715
