UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054297 |
|---|---|
| Receipt number | R000062021 |
| Scientific Title | Goreisan Prospective Randomized Evaluation Extension Study |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/05/02 11:48:32 |
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Basic information
Public title
Goreisan Prospective Randomized Evaluation Extension Study
Acronym
GENERAL Extension Study
Scientific Title
Goreisan Prospective Randomized Evaluation Extension Study
Scientific Title:Acronym
GENERAL Extension Study
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to assess the effect of Goreisan on kidney function in patients with chronic kidney disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
eGFR slope
Key secondary outcomes
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 who particilated "Goreisan Prospective Randomized Evaluation Study"
2. Patients who provide written consent
Key exclusion criteria
1. Patients who are judged to be inappropriate for participation in this study by a local investigator
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Fujii |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Nephrology and Kidney Center
Zip code
650-0017
Address
7-5-1, Kusunokicho, Chuoku, Kobe, Japan
TEL
078-382-6500
fhideki@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Goto |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Nephrology and Kidney Center
Zip code
650-0017
Address
7-5-1, Kusunokicho, Chuoku, Kobe, Japan
TEL
078-382-6500
Homepage URL
sgoto@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Hideki Fujii
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
The Ethics Committee at Kobe University Graduate School of Medicine
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel
078-382-6669
kansatsu@med.kobe-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
| 2024 | Year | 10 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 05 | Month | 01 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062021
