UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030426
Receipt number R000034740
Scientific Title Usefulness of recommbinant thrombomodulin (rTM) in the prevention for hematopoietic stem cell transplantation related complication: multicenter joint research project
Date of disclosure of the study information 2018/02/01
Last modified on 2017/12/16 07:35:43

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Basic information

Public title

Usefulness of recommbinant thrombomodulin (rTM) in the prevention for hematopoietic stem cell transplantation related complication: multicenter joint research project

Acronym

NEWS-RT (New SIGHT Research in Transplantation)

Scientific Title

Usefulness of recommbinant thrombomodulin (rTM) in the prevention for hematopoietic stem cell transplantation related complication: multicenter joint research project

Scientific Title:Acronym

NEWS-RT (New SIGHT Research in Transplantation)

Region

Japan


Condition

Condition

Hematopoietic stem cell transplantation

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The prevention for hematopoietic stem cell transplantation-related complication and recommbinant thrombomodulin (rTM)

Basic objectives2

Others

Basic objectives -Others

The hematopoietic stem cell transplantation-related complication and biomarker

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Comparison between two groups for hematopoietic stem cell transplantation-related complication in periods from day 0 to day 28

Key secondary outcomes

Comparison between two groups for some biomarkers in periods from day 0 to day 28


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

from conditioning to day 21 after HST

Interventions/Control_2

Nothing

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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1. BMT or PBSCT
2. recovery patients
3. Performance status (PS) 0-2
4. HLA compatible (5/6)
5. good function of internal organs (heart, lung, liver and kidney) and SpO2 >95%
6. MAST conditioning
7. creatinine < 1.5 mg/dL
8. AST and ALT < 100 U/L
9. Age 20- 65 years
10. informed concent

Key exclusion criteria

1. severe complications
2. contraindication of rTM
3. sensitivity for rTM
4. eGFR < 30mL/min/1.73m2
5. pregnancy, rectation period
6. inappropriate patients

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shosaku Nomura

Organization

Kansai Medical University

Division name

First Department of Internal Medicine

Zip code


Address

2-5-1, Shinmachi, Hirakata, Osaka Japan

TEL

072-804-2754

Email

nomurash@hirakata.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shosaku Nomura

Organization

Kansai Medical University

Division name

First Department of Internal Medicine

Zip code


Address

2-5-1, Shinmachi, Hirakata, Osaka Japan

TEL

072-804-2754

Homepage URL


Email

nomurash@hirakata.kmu.ac.jp


Sponsor or person

Institute

Kansai Medical University

Institute

Department

Personal name



Funding Source

Organization

Kansai Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 01 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

Enrolling by invitation

Date of protocol fixation

2017 Year 12 Month 16 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 01 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

2017 Year 12 Month 16 Day

Last modified on

2017 Year 12 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034740


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name