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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013880
Receipt No. R000016194
Scientific Title A prospective cohort study for evaluating rissk of renal function and survival in patients with polycystic kidney and liver disease
Date of disclosure of the study information 2014/06/30
Last modified on 2019/05/08

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Basic information
Public title A prospective cohort study for evaluating rissk of renal function and survival in patients with polycystic kidney and liver disease
Acronym PKD cohort study
Scientific Title A prospective cohort study for evaluating rissk of renal function and survival in patients with polycystic kidney and liver disease
Scientific Title:Acronym PKD cohort study
Region
Japan

Condition
Condition polycystic kidney disease, polycystic liver disease
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine risks of end stage renal disease and survival in patients with polycystic kidney and liver diseases, with analyzing epidemiology of the disease in Japan.
Basic objectives2 Others
Basic objectives -Others To evaluate cystic growth; and incidence of cerebrovascular disease, heart disease, and respiratory disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes renal failure and survival
Key secondary outcomes Change of cystic volume. Incidence of cerebrovascular disease, heart disease, and respiratory disease.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with polycystic kidney disease and/or polycystic liver disease.
Key exclusion criteria Patients who are not willing to enroll the study, and those who are considered not eligible to this study.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Yoshifumi
Middle name
Last name Ubara
Organization Toranomon Hospital Kajigaya
Division name Nephrology Center
Zip code 2138587
Address 1-3-1, Kajigaya, Takatsu-ku, Kawasaki, Kanagawa
TEL 044-877-5111
Email ubara@toranomon.gr.jp

Public contact
Name of contact person
1st name Junichi
Middle name
Last name Hoshino
Organization Toranomon Hospital
Division name Nephrology Center
Zip code 1058470
Address 2-2-2, Toranomon, Minato-ku, Tokyo
TEL 03-3588-1111
Homepage URL
Email hoshino@toranomon.gr.jp

Sponsor
Institute Nephrology Center, Toranomon Hospital
Institute
Department

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 IRB, Toranomon Hospital
Address 2-2-2, Toranomon, Minato-ku
Tel 0335881111
Email chiken-jim@toranomon.gr.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 虎の門病院(東京都)、虎の門病院分院(神奈川県)

Other administrative information
Date of disclosure of the study information
2014 Year 06 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 Enrolling by invitation
Date of protocol fixation
2014 Year 05 Month 07 Day
Date of IRB
2014 Year 06 Month 30 Day
Anticipated trial start date
2014 Year 06 Month 30 Day
Last follow-up date
2024 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Blood and urine samples, and related examinations will be performed as daily practice. A part of samples would be stored for further evaluation of outcomes.

Management information
Registered date
2014 Year 05 Month 02 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016194

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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