UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023067 |
|---|---|
| Receipt number | R000026270 |
| Scientific Title | Analysis of risk factors for complications after percutaneous kidney biopsy |
| Date of disclosure of the study information | 2016/07/11 |
| Last modified on | 2017/07/09 17:11:56 |
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Basic information
Public title
Analysis of risk factors for complications after percutaneous kidney biopsy
Acronym
Analysis of risk factors for complications after percutaneous kidney biopsy
Scientific Title
Analysis of risk factors for complications after percutaneous kidney biopsy
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | 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
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-7235
hitoshis@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Tanaka |
Organization
Okayama University Graduate School of Medicine, Dentistry, Pharmaceutical Sciences
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-7235
Homepage URL
ta0-keiko@okayama-u.ac.jp
Sponsor or person
Institute
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Okayama University Graduate School of Medicine, Dentistry, Pharmaceutical Sciences
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026270
