UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of risk factors for complications after percutaneous kidney biopsy
Title of the study (Brief title)	Analysis of risk factors for complications after percutaneous kidney biopsy
Region	Japan

Condition
Condition	patients with suspected kidney disease, who underwent kidney biopsy
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the risk factors for complications after percutaneous kidney biopsy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	a more than 10% decrease in hemoglobin after biopsy
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	15 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients with suspected kidney disease, who underwent kidney biopsy at our Division from January 2010 to March 2016.
Key exclusion criteria	The patients who refuse to participate this research
Target sample size	630

Research contact person
Name of lead principal investigator	Hitoshi Sugiyama
Organization	Okayama University Graduate School of Medicine, Dentistry, Pharmaceutical Sciences
Division name	Department of Human Resource Development of Dialysis Therapy for Kidney Disease
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-7235
Email	hitoshis@md.okayama-u.ac.jp

Public contact
Name of contact person	Keiko Tanaka
Organization	Okayama University Graduate School of Medicine, Dentistry, Pharmaceutical Sciences
Division name	Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-7235
Homepage URL
Email	ta0-keiko@okayama-u.ac.jp

Sponsor
Institute	Department of Nephrology, Rheumatology, Endocrinology and Metabolism Okayama University Graduate School of Medicine, Dentistry, Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	No Funding Source
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2016 Year 07 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2017 Year 03 Month 14 Day
Date analysis concluded	2017 Year 03 Month 14 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Observational Study

Management information
Registered date	2016 Year 07 Month 07 Day
Last modified on	2017 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026270