UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014674
Receipt No. R000017066
Scientific Title ADPKD cohort study
Date of disclosure of the study information 2014/07/28
Last modified on 2019/04/03

* 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 ADPKD cohort study
Acronym ADPKD cohort study
Scientific Title ADPKD cohort study
Scientific Title:Acronym ADPKD cohort study
Region
Japan

Condition
Condition autosomal dominant polycystic kidney disease(ADPKD)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We investigate the increase speed of the kidney capacity of the autosomal dominant polycystic kidney disease (ADPKD) patient and renal function aggravation speed. In addition, We examine the frequency of complications in ADPKD and prevalence in Ibaraki.
Basic objectives2 Others
Basic objectives -Others 1)Epidemiology investigation and complications in ADPKD
2)Influence of quality of life (QOL) and the hypoxemia
3)Effect of tolvaptan
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes the increase of kidney volume
Key secondary outcomes (1) Aggravation speed of renal function (eGFR or the inulin clearance
(2) Death
(the cause of death:) Infectious disease, malignant tumor, cardiovascular disease, cerebropathy, liver failure, respiratory failure, sudden death, other (accident, fall) ignorance)
(3) Kidney composition endpoint (more than 25% drop of dialysis introduction, renal transplantation, 1/sCr or eGFR, renal artery embolus therapy)
(4) Cardiovascular event (cerebral hemorrhage, subarachnoid hemorrhage, cerebral infarction, myocardial infarction, angina, heart failure, peripheral artery stenosis to need hospitalization)
(5) Infectious disease (cyst infection, large intestine diverticulitis) to need hospitalization
(6) Cyst bleeding to need hospitalization
(7) Serious liver damage
(an ascent more than the twice the standard value upper limit of total bilirubin and a rise more than 3 times of the standard value upper limit in serum ALT or AST)
(8) Kidney plasma flow quantity
(9) Prevalence
(10) Gene variation

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 ADPKD
Key exclusion criteria The patient who study responsibility doctor or study allotment doctor judged inappropriate patient.
The patient who was not agreed informed consent.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Kunihiro
Middle name
Last name Yamagata
Organization university of tsukuba,faculty of medicine
Division name department of nephrology
Zip code 305-8575
Address 1-1-1,Tennodai,Tsukuba,Ibaraki, Japan
TEL 029-853-3202
Email k-yamaga@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name Hirayasu
Middle name
Last name Kai
Organization university of tsukuba,faculty of medicine
Division name department of nephrology
Zip code 3058575
Address 1-1-1,Tennodai,Tsukuba,Ibaraki, Japan
TEL 029-853-3202
Homepage URL
Email hirayasu.kai@md.tsukuba.ac.jp

Sponsor
Institute university of tsukuba,faculty of medicine,department of nephrology
Institute
Department

Funding Source
Organization university of tsukuba,faculty of medicine,department of nephrology,Money of authorized accounting
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tsukuba Clinical Research & Development Organization
Address Tsukuba city, Amakubo, 2-1-1
Tel 0298533914
Email rinshokenkyu@un.tsukuba.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

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 28 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
2014 Year 06 Month 13 Day
Date of IRB
2014 Year 06 Month 14 Day
Anticipated trial start date
2014 Year 06 Month 14 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 200 patients in ADPKD would be enrolled.
A registration period: From an Ethical Review Board approval day to March 31, 2019.

Management information
Registered date
2014 Year 07 Month 28 Day
Last modified on
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017066

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.