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 | 2024/08/15 10:26:50 |
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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
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
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
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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 16 | Day |
Last modified on
| 2024 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034740
