UMIN-CTR Clinical Trial

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 Akinari Middle name Last name Sekine
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	akinari-s@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	2022 Year 05 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016194