UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041030 |
|---|---|
| Receipt number | R000046830 |
| Scientific Title | A non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT in subjects with acute spinal cord injury |
| Date of disclosure of the study information | 2020/07/18 |
| Last modified on | 2024/02/06 13:10:12 |
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Basic information
Public title
Phase 3 study of KP-100IT in subjects with acute spinal cord injury
Acronym
Phase 3 study of KP-100IT in subjects with acute spinal cord injury
Scientific Title
A non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT in subjects with acute spinal cord injury
Scientific Title:Acronym
A non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT in subjects with acute spinal cord injury
Region
| Japan |
Condition
Condition
Acute spinal cord injury
Classification by specialty
| Orthopedics | Emergency medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A study to confirm efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Percentage of subjects with an improvement of at least two AIS grade, A to C/D, at 24 weeks after administration
Key secondary outcomes
1. Time course of ASIA motor score (total/ upper extremity / lower upper extremity)
2. Time course of ASIA sensory score
3. Time course of AIS classification
4. Time course of modified Frankel classification
5. Time course of neurological level of injury
6. Percentage of subjects improving by at least 10 points on the ASIA motor score at 12 weeks and 24 weeks after administration relative to before study drug administration
7. Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100IT after intrathecal administration
8. Evaluation of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intrathecal injection of KP-100IT
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
| 18 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-At the time of consent (whether oral or written consent), the patient's age is over 18 years old and under 89 years old
-Patients who have suffered a cervical spinal cord injury within the past 78 hours whose AIS classification was A at 66 - 78 hours after injury-Written informed consent has been obtained
Key exclusion criteria
-The injury site is C1 - C2 or C2 - C3
-The patient cannot start rehabilitation necessary for recovery of function at an early stage, for example because tracheal intubation, tracheotomy, or mechanical ventilatory support is necessary
-It is predicted that it will not be possible to administer the first dose of the study drug within 78 hours after the cervical spinal cord injury
-A history of spinal cord injury (SCI), or abnormal findings in the spinal cavity or marked breakdown of the meninges other than SCI
-Efficacy and safety cannot be evaluated properly due to such as concurrent multiple external trauma or concurrent organ injury
-High dose steroid therapy administered for spinal cord injury
-Disease such as serious liver disorder, renal disease, heart disease, blood dyscrasia, metabolic disease, or infections requiring systemic therapy
-History of malignant tumor
-Participation in a clinical study or research of pharmaceuticals or medical devices within 1 month before registration
-Drug allergies to drugs that will be (or may be) used
-Administration of the study drug to the site of spinal cord injury is inappropriate for a reason such as intrathecal infection or intrathecal mass
-Problems with the subject's ability to give informed consent in person
-The subject is breastfeeding or possibly pregnant
-The subject cannot be expected to survive more than 180 days after the start of administration of the study drug, in the judgement of the investigator
-It is inappropriate for the subject to be included in the study, in the judgement of the investigator
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Daichika |
| Middle name | |
| Last name | Hayata |
Organization
Kringle Pharma, Inc.
Division name
Department of Pharmaceutical Development
Zip code
5620013
Address
Saito Biotechnology Incubator 207, 7-7-15 Saito-Asagi, Ibaraki, Osaka 567-0085 Japan
TEL
072-641-8739
hayata@kringle-pharma.com
Public contact
Name of contact person
| 1st name | Yurika |
| Middle name | |
| Last name | Abe |
Organization
Kringle Pharma, Inc.
Division name
Department of Pharmaceutical Development
Zip code
5620013
Address
Saito Biotechnology Incubator 207, 7-7-15 Saito-Asagi, Ibaraki, Osaka 567-0085 Japan
TEL
072-641-8739
Homepage URL
y.abe@kringle-pharma.com
Sponsor or person
Institute
Kringle Pharma, Inc.
Institute
Department
Personal name
Funding Source
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Haradoi hospital Institutional Review Board
Address
6-40-8 Aoba, Higashi-ku, Fukuoka-shi, Fukuoka
Tel
092-691-3881
irb@haradoi-hospital.com
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
総合せき損センター(福岡県)、北海道せき損センター(北海道)、村山医療センター（東京都）、神戸赤十字病院（兵庫県）、愛仁会リハビリテーション病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 18 | 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
| 2020 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 28 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 08 | Day |
Last modified on
| 2024 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046830
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