UMIN-CTR Clinical Trial

Basic information
Public title	Research on the pathogenesis of autosomal dominant polycystic kidney disease
Acronym	ADPKD-Hokkaido-1
Scientific Title	Research on the pathogenesis of autosomal dominant polycystic kidney disease
Scientific Title:Acronym	ADPKD-Hokkaido-1
Region	Japan

Condition
Condition	Autosomal dominant polycystic kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To explore prognostic factors in Japanese patients with ADPKD based on information in electronic medical charts and genetic information collected from patients with ADPKD who have visited or been admitted to Hokkaido University Hospital or its related hospitals
Basic objectives2	Others
Basic objectives -Others	Risk factors for increase in kidney volume, which is considered a surrogate marker of reduction in renal function, as well as complications such as cerebral aneurysm, will be explored
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of factors that may affect the progression of ADPKD (annual percentage change in kidney volume)
Key secondary outcomes	Evaluation of factors that may affect the progression of ADPKD (annual change in eGFR) Exploration of factors that may affect the onset of ADPKD-related events (cerebral aneurysm, hypertension, urolithiasis, renal pain, macroscopic hematuria, cyst infection, urinary tract infection, proteinuria, dialysis, and other ADPKD-related events) and other major events (e.g., cardiovascular events) Comparison of genetic background information between subjects and healthy adults

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 with a diagnosis of ADPKD who have visited or been admitted to Hokkaido University Hospital or its related hospitals at least twice Patients who meet the following criterion if blood and/or urine samples will be collected: - Patients who are capable to consent
Key exclusion criteria	Patients who meet the following criterion if blood and/or urine samples will be collected: - Patients who, in the opinion of the investigator, are inappropriate for the study
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Saori Middle name Last name Nishio
Organization	Hokkaido University School of Medicine
Division name	Department of Medicine II
Zip code	060-8648
Address	Kita 14, Nishi 5, Kita-ku, Sapporo, Japan
TEL	011-706-5915
Email	saorin@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Saori Middle name Last name Nishio
Organization	Hokkaido University School of Medicine
Division name	Department of Medicine II
Zip code	060-8648
Address	Kita 14, Nishi 5, Kita-ku, Sapporo, Japan
TEL	011-706-5915
Homepage URL
Email	saorin@med.hokudai.ac.jp

Sponsor
Institute	Otsuka Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hokkaido University
Address	Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
Tel	+81-11-706-5915
Email	saorin@med.hokudai.ac.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	北海道大学病院（北海道）、北見赤十字病院（北海道）、旭川医科大学（北海道）

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 02 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	255
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	We need time to analyze the data.
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	No longer recruiting
Date of protocol fixation	2015 Year 10 Month 13 Day
Date of IRB	2015 Year 09 Month 29 Day
Anticipated trial start date	2015 Year 11 Month 10 Day
Last follow-up date	2016 Year 10 Month 31 Day
Date of closure to data entry	2018 Year 04 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other

Other related information

Evaluation of factors that may affect the progression of ADPKD (annual change in eGFR) Exploration of factors that may affect the onset of ADPKD-related events (cerebral aneurysm, hypertension, urolithiasis, renal pain, macroscopic hematuria, cyst infection, urinary tract infection, proteinuria, dialysis, and other ADPKD-related events) and other major events (e.g., cardiovascular events) Comparison of genetic background information between subjects and healthy adults

Management information
Registered date	2015 Year 11 Month 02 Day
Last modified on	2021 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022372