UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000019504
Receipt number	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 09:21:15

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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

Any conditions that are the indication of percutaneous renal biopsy

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

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

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

Intervention

No. of arms

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

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 or person

Institute

Kyoto University

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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