UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044110 |
|---|---|
| Receipt number | R000048646 |
| Scientific Title | Online survey and patient advisory board for chronic kidney disease patients in Japan - A study of the experiences and perceptions of patients with chronic kidney disease using mixed research methods - |
| Date of disclosure of the study information | 2021/12/22 |
| Last modified on | 2021/05/11 12:12:14 |
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Basic information
Public title
Online survey and patient advisory board for chronic kidney disease patients in Japan
- A study of the experiences and perceptions of patients with chronic kidney disease using mixed research methods -
Acronym
An online survey and patient advisory board for chronic kidney disease patients in Japan
Scientific Title
Online survey and patient advisory board for chronic kidney disease patients in Japan
- A study of the experiences and perceptions of patients with chronic kidney disease using mixed research methods -
Scientific Title:Acronym
An online survey and patient advisory board for chronic kidney disease patients in Japan
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the disease and treatment experiences and perceptions of patients with chronic kidney disease (CKD) to understand patient needs and expectations for new treatments and clinical trials.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 Information about patient background, experiences and perceptions of the disease and treatment of CKD patients obtained from patient surveys
2 Information about CKD patients' experiences and perceptions of the disease and treatment obtained by the Patient Advisory Board
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Patients who have been diagnosed with CKD
-Patients who can access the website and complete the survey
-Patients willing to participate in a patient advisory board to be held at a later date
-Patients whose consent has been obtained from the patient on the website prior to the start of this study
Key exclusion criteria
-Patients on maintenance dialysis (hemodialysis, peritoneal dialysis) or scheduled for induction
-Patients who have undergone or will undergo kidney transplantation
Target sample size
306
Research contact person
Name of lead principal investigator
| 1st name | Nobutaka |
| Middle name | |
| Last name | Yagi |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Medicine Division
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL
03-6417-2043
nobutaka.yagi@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Nobutaka |
| Middle name | |
| Last name | Yagi |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Medicine Division
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL
03-6417-2043
Homepage URL
nobutaka.yagi@boehringer-ingelheim.com
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Kyoso-kai AMC Nishi-Ume da Clinic Ethics Review Committee
Address
Maruit Nishi-Umeda Building 3F, 3-3-45 Umed a, Kita-ku, Osaka-shi, Osaka, Japan
Tel
06-4797-5660
morikawa@amc-clinic.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
| 2021 | Year | 12 | Month | 22 | 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
347
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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient Survey
The investigator will collect information about the experience and perceptions of CKD diagnosis/treatment through a web-based patient survey. Details of this information
Patient Advisory Board
The principal investigator will hold a Patient Advisory Board meeting online. The meeting is expected to last approximately 4 hours. The principal investigator may lend equipment necessary to conduct the online meeting to research subjects participating in the Patient Advisory Board.
Based on the results of the patient questionnaire, the principal investigator will collect detailed information from the study subjects themselves about their specific current patient burden and their needs and expectations for future treatment in terms of the perspectives shown in State, Emotions, Information, Views and Actions.
Management information
Registered date
| 2021 | Year | 05 | Month | 05 | Day |
Last modified on
| 2021 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048646
