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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019504
Receipt No. R000022545
Scientific Title The Effect of Intravenous Tranexamic Acid in Percutaneous Renal Biopsy: A Single Center, Triple-blinded Randomized Controlled Trial
Date of disclosure of the study information 2015/11/16
Last modified on 2015/11/18

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Basic information
Public title The Effect of Intravenous Tranexamic Acid in Percutaneous Renal Biopsy: A Single Center, Triple-blinded Randomized Controlled Trial
Acronym TRANEPSY study
Scientific Title The Effect of Intravenous Tranexamic Acid in Percutaneous Renal Biopsy: A Single Center, Triple-blinded Randomized Controlled Trial
Scientific Title:Acronym TRANEPSY study
Region
Japan

Condition
Condition Any conditions that are the indication of percutaneous renal biopsy
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether tranexamic acid in percutaneous renal biopsy is effective to reduce bleeding and
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Perirenal hematoma measured by using ultrasonography on the next morning after percutaneous renal biopsy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Higher dose of tranexamic acid (TA): 1,000mg
TA will be administered intravenously with the bolus dose of 500mg just before the renal biopsy, then administered intravenously with the continuous dose of 500mg in normal saline after the procedure.
Interventions/Control_2 Lower dose of tranexamic acid (TA): 500mg
TA will be administered intravenously with the bolus dose of 250mg just before the renal biopsy, then administered intravenously with the continuous dose of 250mg in normal saline after the procedure.
Interventions/Control_3 Normal saline (NS): Placebo
NS will be administered intravenously with the equivalent bolus dose just before the renal biopsy, then administered intravenously with the equivalent continuous dose in normal saline after the procedure.
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 Inclusion criteria will be adult patients who are aged 20 years or more, and who will undergo percutaneous biopsy of the native kidney.
Key exclusion criteria Exclusion criteria will be patients who are suspected of amyloidosis, who have any contraindication of tranexamic acid, who are pregnant or breast-feeding, who need tranexamic acid for treatment or who are thought not to be suitable to participate in the study.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichi Matsuzaki
Organization Kyoto University
Division name Department of Preventive Services, Kyoto University Graduate School of Public Health
Zip code
Address Kyoto University Health Service, Yoshida-Honmachi, Sakyo-ku, Kyoto, Japan, 606-8501
TEL 075-753-2426
Email matsuzaki.keiichi.4v@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Izawa
Organization Kyoto University
Division name Department of Preventive Services, Kyoto University Graduate School of Public Health
Zip code
Address Kyoto University Health Service, Yoshida-Honmachi, Sakyo-ku, Kyoto, Japan, 606-8501
TEL 075-753-2426
Homepage URL
Email jizawa13@gmail.com

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Kyoto University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 沖縄県立中部病院 (沖縄県)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 16 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 Terminated
Date of protocol fixation
2015 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 26 Day
Last modified on
2015 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022545

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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