UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003977 |
|---|---|
| Receipt number | R000004768 |
| Scientific Title | Islet transplantation using brain-dead donors and donors after cardiac death for patients with insulin-dependent diabetes mellitus suffering from complicating hypoglycemia unawareness |
| Date of disclosure of the study information | 2010/11/01 |
| Last modified on | 2021/04/18 19:19:45 |
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Basic information
Public title
Islet transplantation using brain-dead donors and donors after cardiac death for patients with insulin-dependent diabetes mellitus suffering from complicating hypoglycemia unawareness
Acronym
Islet transplantation using brain-dead donors and donors after cardiac death for type 1 diabetes
Scientific Title
Islet transplantation using brain-dead donors and donors after cardiac death for patients with insulin-dependent diabetes mellitus suffering from complicating hypoglycemia unawareness
Scientific Title:Acronym
Islet transplantation using brain-dead donors and donors after cardiac death for 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 primary objective is to verify the effect of the immunosuppressants by confirming the existing islet graft function that can lead to glycemic stability. The secondary objective is to confirm the safety of using these immunosuppressants for long periods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The proportion of subjects with HbA1c<7.0% and who are free of severe hypoglycemic events (from day 90 to day 365) one years after the first islet cell infusion.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Immunosuppressant
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
1. Male or female; 20 to 65 years of age.
2. Ability to provide written informed consent.
3. Mentally stable and able to comply with the procedures of the study protocol.
4. Clinical history compatible with type 1 diabetes with insulin dependence for > 5 years at the time of the registration.
5. Absent stimulated C-peptide (< 0.3 ng/mL)
6. Involvement in intensive diabetes management defined as the self monitoring of glucose values no less than a mean of three times each day, averaged over each week, and the administration of three or more insulin injections each day or insulin pump therapy. Such management must have been subjected to at least 3 clinical evaluations during the previous 12 months.
7. At least one episode of severe hypoglycemia in the past 12 months defined as an event with symptoms compatible with hypoglycemia in which the subject required the assistance of another person and which was associated with either a blood glucose level < 54 mg/dL (3.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.
8. At least once evaluated glycemic lability status by a Clarke score, a HYPO score and a glycemic lability index (LI) score.
Key exclusion criteria
1. BMI > 27 kg/m2 or weight > 80 kg.
2. Insulin requirement of > 0.8 IU/kg/day or 55 U/day.
3. Mean HbA1c value of several measurements in the previous 12 months > 10%.
4. Untreated proliferative diabetic retinopathy.
5. Blood pressure: SBP > 160 mmHg or DBP > 100 mmHg.
6. Creatinine clearance < 60 mL/min (applied only to islet transplantation alone case)
7. Presence of proteinuria > 1 g/day.
8. For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3 months after discontinuation. For male participants: Intent to procreate during the duration of the study or within 3 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant, Depo-Provera, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
9. Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB. Positive tests are acceptable only if associated with a history of previous vaccination in the absence of any sign of active infection. Positive tests are otherwise not acceptable, even in the absence of any active infection at the time of evaluation.
10. Negative screen for Epstein-Barr Virus (EBV) by IgG determination.
11. Difficulty of administration for laboratory and physical tests for evaluation or regular outpatient visits.
12. Mental abnormalities to hinder medical procedure under protocol (Assessment by psychiatrists is required and final decision is made by investigators in charge)
13. Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Marubashi |
Organization
Fukushima Medical University
Division name
Department of Hepato-Biliary-Pancreatic Surgery
Zip code
960-1295
Address
1 Hikarigaoka Fukushima, Japan
TEL
024-547-1254
jpitx@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Anazawa |
Organization
Fukushima Medical University/Kyoto University
Division name
Department of Regenerative Surgery/Department of Surgery
Zip code
960-1295
Address
1 Hikarigaoka Fukushima, Japan
TEL
024-547-1254
Homepage URL
anazawa@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
The Japanese Pancreas and Islet Transplantation Association
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
Hikarigaoka 1 Fukushima
Tel
024547111
rs@fmu.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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | 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
9
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Data analysis in progress
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
Terminated
Date of protocol fixation
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 02 | Day |
Last modified on
| 2021 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004768
