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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000003977 |
Receipt No. | 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 | 2019/08/10 |
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 |
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Condition | |||
Condition | Type 1 diabetes | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | The Japanese Pancreas and Islet Transplantation Association
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Institute | |
Department |
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 |
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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 | |
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 | No longer recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004768 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |