UMIN-CTR Clinical Trial

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
Email	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
Email	nobutaka.yagi@boehringer-ingelheim.com

Sponsor
Institute	Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048646