UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019395 |
|---|---|
| Receipt number | R000022374 |
| Scientific Title | Clinical Enforcement of islet cell transplantation in our hospital |
| Date of disclosure of the study information | 2015/10/20 |
| Last modified on | 2023/10/26 18:22:17 |
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Basic information
Public title
Clinical Enforcement of islet cell transplantation in our hospital
Acronym
Clinical islet transplantation in Japanese patients with type 1 diabetes
Scientific Title
Clinical Enforcement of islet cell transplantation in our hospital
Scientific Title:Acronym
Clinical islet transplantation in Japanese patients with type 1 diabetes
Region
| Japan |
Condition
Condition
Patients uncontrolled severe type 1 diabetes
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical islet transplantation for uncontrolled type 1 diabetes patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of insulin independence
The rate of graft survival
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
| Maneuver |
Interventions/Control_1
Clinical islet transplantation for uncontrolled type 1 diabetes patients.
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) Age is between 20 and 65 years old at the time of informed consent.
2) Written consent is necessary from the patient.
3) Patient need to obey the protocol.
4) The duration of type 1 DM is at least more than five years.
5) Endogenous insulin secretion is exhausted.(basal C-peptide <0.1 ng/ml)
6) Patient need to receive the basal-bolus insulin therapy.
7) Patient have severe hypoglycemia episodes in the past 12 months
8) Patients need to have datas (Clark Score, HYPO Score, Lability Index).
In case of islet transplantation after kidney transplantation, need a consultation and agreement with kidney transplant doctor.
Following selection criteria are added.
- IAK-1: Passed more than six months after renal transplantation.
- IAK-2: Serum creatinine level is less than 1.8mg/dl. The elevation of serum creatinine level is less than 0.2mg/dl during recent 6 months and no remarkable sustained elevation
-IAK-3: Oral intake of steroids (prednisone equivalent)is less than 10mg/day.
Key exclusion criteria
1.Body weight is greater than 80kg,or BMI is greater than 25kg/m2.
2.Insulin dose is over 0.8IU/kg/day day, or more than 55U/day.
3/The average value of HbA1C is more than 10.4% in the past year.
4.Patient has untreated proliferative diabetic retinopathy.
5.Systolic blood pressure is above 160mmHg or diastolic blood pressure is over 100mmHg.
6.eGFR is less than 60ml/min/1.73m2 (In case of islet transplantation alone).
7.Urine protein is more than 1g/day.
8.PRA(panel reactive antibody)is above 20%by flow cytometry.
9.Pregnancy test is positive or under the nursing.
10.Patient has following active infections.
Hepatitis B or C, HIV, HTLV-I,or
acid bacteriosis including tuberculosis.
11.Epstein-Barr IgG antibody is negative.
12.Patient has a history of invasive aspergillosis infection.
13.Patient has a history of cancer. However, completely resected squamous cell carcinoma or basal cell carcinoma of the skin is excluded.
14.Alchoholic or drug addict
15.Hemoglobin level is below normal limit; lymphopenia (<700/µL), neutropenia (<1,500/µL), or thrombocytopenia (platelets <100,000/µL).
16.Patient has a history of factor V deficiency.
17.Coagulation disorder or Anticoagulants are needed after transplantation.
18.Severe heart disease
1)Myocardial infarction in past past 6 months.
2)Ischemic heart failure that is diagnosed by cardiac function test in past one year.
3)Ejection fraction is less than 30%.
19.Liver function test values are sustained high AST,ALT(ALP, or total bilirubin values, continues more than 1.5 times the upper limit of normal)
20.Symptomatic cholelithiasis.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Eguchi |
Organization
Nagasaki University Hospital
Division name
Department of SURGERY
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7316
sueguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichirou Ono |
Organization
Nagasaki University Hospital
Division name
Department of SURGERY
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7316
Homepage URL
shinichi0320_com@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 10 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
21.Acute or chronic pancreatitis
22.Symptomatic peptic ulcer.
23.Severe frequent diarrhea, vomiting or gastrointestinal disorder that may disturb the oral drug absorption.
24.Treatment resistance hyperlipidemia (fasting LDL cholesterol exceeds 130mg/dl or neutral fats fasting exceeds 200mg/dl
25.Undergoing steroid treatment
26.Administration of the drug in other clinical trials
27.Received the inoculation of live attenuated vaccine within two months.
28.Patient cant take hospitalization and outpatient clinic for the necessary examination.
29.Mental disorder
30.Patient who is determined to be inappropriate by the attending physician
Management information
Registered date
| 2015 | Year | 10 | Month | 19 | Day |
Last modified on
| 2023 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022374
