UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042300 |
|---|---|
| Receipt number | R000048257 |
| 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 methods research - |
| Date of disclosure of the study information | 2020/10/30 |
| Last modified on | 2020/10/30 17:59:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 methods research -
Acronym
A study of the experiences and perceptions of patients with chronic kidney disease using mixed methods research
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 methods research -
Scientific Title:Acronym
A study of the experiences and perceptions of patients with chronic kidney disease using mixed methods research
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the experiences and perceptions of the disease and treatment of patients with chronic kidney disease (CKD) in order 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 on patient background and CKD patients' experiences and perceptions of the disease and treatment from patient surveys
2) Information about CKD patients' experiences and perceptions of the disease and treatment from 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 meet all of the following criteria at the time of enrollment in this study will be eligible for this study
1) Patients aged 20 years or older
2) Patients with a diagnosis of CKD
3) Patients who can access the website and complete the survey
4) Patients willing to participate in the Patient Advisory Board to be held at a later date
5) Patients whose consent is obtained from the patient on the website prior to the start of this study
Key exclusion criteria
Patients who meet any of the exclusion criteria will not be enrolled in this study
1) Patients on maintenance dialysis (hemodialysis or peritoneal dialysis) or who planed those
2) Patients who have received or planned to receive a kidney transplant
Target sample size
300
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-Umeda Clinic Ethics Review Committee
Address
Maruit Nishi-Umeda Building 3F, 3-3-45 Umeda, 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
| 2020 | Year | 10 | Month | 30 | 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
| 2020 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study will collect data by web-based patient questionnaire and a patient advisory board.
Patient questionnaires will collect information on experiences and perceptions of CKD diagnosis and treatment.
A patient advisory board will collect detailed information on patient burden and future treatment needs and expectations.
Management information
Registered date
| 2020 | Year | 10 | Month | 30 | Day |
Last modified on
| 2020 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048257
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
