UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053362 |
|---|---|
| Receipt number | R000060907 |
| Scientific Title | Nationwide survey on the use of basiliximab (genetical recombination) for prevention of acute rejection after transplantations |
| Date of disclosure of the study information | 2024/01/22 |
| Last modified on | 2024/02/09 09:40:35 |
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Basic information
Public title
Nationwide survey on the use of basiliximab (genetical recombination) for prevention of acute rejection after transplantations
Acronym
Nationwide survey on the use of basiliximab (genetical recombination)
Scientific Title
Nationwide survey on the use of basiliximab (genetical recombination) for prevention of acute rejection after transplantations
Scientific Title:Acronym
Nationwide survey on the use of basiliximab (genetical recombination) for prevention of acute rejection after transplantations
Region
| Japan |
Condition
Condition
This study focuses on patients* who received basiliximab as induction therapy during organ transplantation from 2016 to 2020 (corresponding cases in nationwide survey conducted by the Japanese Society for Transplantation from 2016 to 2020).
*Patients include domestic cases in which basiliximab was administered before 2016.
Classification by specialty
| Cardiology | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Chest surgery | Pediatrics |
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of basiliximab as measured (evaluated?) by the incidence of adverse events in patients with any transplanted organ (except kidney) during the 6 months after transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of adverse events in patients with any transplanted organ during the 6 months after transplantation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Adults* and pediatric patients in whom patients or his/her legal guardians gave consented to the research approved at the Ethics Committee by informed consent or are guaranteed the opportunity to refuse the data of use by opt out.
2.Adult and pediatric transplant patients who received basiliximab as induction therapy from January 1st,2016 to December 31st ,2020 ( including patients who received transplantation simultaneously more than one (liver, heart, lung, small intestine, pancreas and islets))
However, patients with transplantation for small intestine before 2016 are also acceptable. In this study, the pharmaceutical definition of adult is 15 years of age or older.
Key exclusion criteria
Patients who received simultaneously organ transplantation of pancreatic and kidney
Target sample size
347
Research contact person
Name of lead principal investigator
| 1st name | AKIHIKO |
| Middle name | |
| Last name | SOYAMA |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Surgery
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
095-819-7316
soyama@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Narumi |
| Middle name | |
| Last name | Tashiro |
Organization
EPS Corporation
Division name
Clinical Research Center Real World Evidence Business Headquarters
Zip code
162-0814
Address
Acropolis Tokyo, 6-29 Shinogawamachi, Shinjuku-ku, Tokyo
TEL
03-6759-9904
Homepage URL
prj-simulect@eps.co.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Japan Society for Transplantation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
Tel
0958197229
gaibushikin@ml.nagasaki-u.ac.jp
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
旭川医科大学病院(北海道)、北海道大学病院(北海道)、東北大学病院(宮城県)、岩手医科大学附属病院(岩手県)、埼玉医科大学国際医療センター(埼玉県)、
千葉大学医学部附属病院(千葉県)、国立研究開発法人 国立成育医療研究センター(東京都)、東京女子医科大学病院(東京都)、東京大学医学部附属病院(東京都)、名古屋大学医学部附属病院(愛知県)、藤田医科大学病院(愛知県)、
京都大学医学部附属病院(京都府)、大阪大学医学部附属病院(大阪府)、国立研究開発法人 国立循環器病研究センター(大阪府)、岡山大学病院(岡山県)、徳島大学病院(徳島県)、九州大学病院(福岡県)、慶應義塾大学病院(東京都)、長崎大学病院(長崎県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 22 | 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
| 2023 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To retrospectively investigate the current status of use of basiliximab for preventing acute rejection after organ transplantations other than kidney transplantations in Japan, and evaluate the safety, efficacy and, dosage and administration of basiliximab. The results of this survey will be used when applying for approval of additional indications for basiliximab.
Management information
Registered date
| 2024 | Year | 01 | Month | 16 | Day |
Last modified on
| 2024 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060907
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
