UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial of immunomodulatory therapy using anti-thymocyte globulin and pegfilgrastim for recently onset type 1 diabetes
Acronym	Immunomodulatory therapy using ATG/PeG-CSF for recently onset type 1 diabetes
Scientific Title	Clinical trial of immunomodulatory therapy using anti-thymocyte globulin and pegfilgrastim for recently onset type 1 diabetes
Scientific Title:Acronym	Immunomodulatory therapy using ATG/PeG-CSF for recently onset type 1 diabetes
Region	Japan

Condition
Condition	Type 1 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety and efficacy of immunomodulatoly therapy using anti-thymocyte globulin and pegfilgrastim in recently onset type 1 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of adverse events during 52 weeks of the treatment or observation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Anti-thymocyte globulin: 0.5 mg/kg (Day 1), 1.5 mg/kg (Day 2)
Interventions/Control_2	Pegfilgrastim: 3.6 mg x 6 times every 2 weeks (starting at Day 3)
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. Acute-onset type 1 diabetes 2. Within 12 months since diagnosis 3. Fasting serum C-peptide > 0.3 ng/mL
Key exclusion criteria	1. Active infection 2. Pregnancy/breast-feeding 3. Past history of malignant tumor 4. Interstitial pneumonia 5. Severe liver or/and kidney dysfunction 6. Past history of ATG administration 7. Under systemic steroid therapy
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Chujo
Organization	Toyama University Hospital
Division name	Center for Clinical Research
Zip code	930-0194
Address	2630, Sugitani, Toyama, Japan
TEL	076-434-2281
Email	dchujo@med.u-toyama.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Chujo
Organization	Toyama University Hospital
Division name	Center for Clinical Research
Zip code	930-0194
Address	2630, Sugitani, Toyama, Japan
TEL	076-434-2281
Homepage URL
Email	dchujo@med.u-toyama.ac.jp

Sponsor
Institute	Toyama University
Institute
Department

Funding Source
Organization	Japan IDDM Network
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Certified Review Board of National Center for Global Health and Medicine
Address	1-21-1, Toyama, Shinjuku, Tokyo, Japan
Tel	03-3202-7181
Email	rinrijm@hosp.ncgm.go.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	2017 Year 04 Month 21 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	12
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	2016 Year 12 Month 27 Day
Date of IRB	2016 Year 12 Month 26 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2023 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 04 Month 19 Day
Last modified on	2021 Year 04 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031003

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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