UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014381 |
|---|---|
| Receipt number | R000016734 |
| Scientific Title | Clinical Study of Allogeneic Islet Transplantation for Treatment of type 1 diabetes |
| Date of disclosure of the study information | 2014/06/26 |
| Last modified on | 2014/06/25 18:41:20 |
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Basic information
Public title
Clinical Study of Allogeneic Islet Transplantation for Treatment of type 1 diabetes
Acronym
Clinical Study of Allogeneic Islet Transplantation for Treatment of type 1 diabetes
Scientific Title
Clinical Study of Allogeneic Islet Transplantation for Treatment of type 1 diabetes
Scientific Title:Acronym
Clinical Study of Allogeneic Islet Transplantation for Treatment of type 1 diabetes
Region
| Japan |
Condition
Condition
Type 1 Diabetes
Classification by specialty
| Endocrinology and Metabolism | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the safety and efficacy of islet transplantation for the treatment of Type 1 Diabetes in subjects with hypoglycemia
unawareness and a history of severe hypoglycemic episodes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of subjects with an HbA1c <7.0% at Day 365 AND free of
severe hypoglycemic events from Day 28 to Day 365 inclusive following the
first islet transplant, with the day of transplant designated Day 0
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Allogeneic Islet Transplantation
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Involvement in intensive diabetes management
Absent basal c-peptide (<0.1ng/mL)
At least one episode of severe hypoglycemia in the 12 months prior to study enrollment
Key exclusion criteria
Body mass index (BMI) >25 kg/m2 or patient weight >80kg.
Insulin requirement of >0.8 IU/kg/day or >55 U/day.
HbA1c >10%.
Untreated proliferative diabetic retinopathy.
Blood Pressure: SBP >160 mmHg or DBP >100 mmHg.
eGFR <60 mL/min/1.73m^2
Presence or history of macroalbuminuria (>1g/day).
Presence or history of panel-reactive anti-HLA antibodies above
background by flow cytometry.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Shimoda |
Organization
Research Institute, National Center for Global Health and Medicine
Division name
Pancreatic islet cell transplantation
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655 Japan
TEL
03-3202-7181
mshimoda@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Shimoda |
Organization
Research Institute, National Center for Global Health and Medicine
Division name
Pancreatic islet cell transplantation
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655 Japan
TEL
03-3202-7181
Homepage URL
mshimoda@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 06 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | 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
| 2014 | Year | 06 | Month | 26 | Day |
Last modified on
| 2014 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016734
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
