UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047441 |
|---|---|
| Receipt number | R000054091 |
| Scientific Title | Real-world study on the efficacy of an adjunctive use of ipragliflozin for prevention of chronic kidney disease in patients with type 1 diabetes |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2022/08/23 13:29:38 |
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Basic information
Public title
Real-world study on the efficacy of an adjunctive use of ipragliflozin for prevention of chronic kidney disease in patients with type 1 diabetes
Acronym
Study on the efficacy of ipragliflozin for prevention of chronic kidney disease in type 1 diabetes
Scientific Title
Real-world study on the efficacy of an adjunctive use of ipragliflozin for prevention of chronic kidney disease in patients with type 1 diabetes
Scientific Title:Acronym
Study on the efficacy of ipragliflozin for prevention of chronic kidney disease in 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
The aim of study is to investigate the effects of ipragliflozin on kidney outcomes as an adjunctive treatment to insulin therapy in Japanese patients with T1D.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome will be determined by the annual rate of change in eGFR (mL/min/1.73 m2) from the initiation of ipragliflozin in the ipragliflozin group compared to those during 24 months equivalent to the period in the control group.
Key secondary outcomes
The secondary outcome will be determined by the composite end point of a sustained reduction in eGFR of > 50 %, or severe impairment of kidney function which was defined as an eGFR <30 mL/min/1.73 m2 (i.e. CKD stage G4 and G5), or doubling time of urinary albumin (protein) per creatine.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients will be recruited to meet all of the following criteria:
1) Diagnosed type 1 diabetes by diabetologists and had more than 5 years history of type 1 diabetes
2) A)Ipragliflozin group (n=120): Patients who administered ipragliflozin more than 24 months before enrollment.
B) Control group (n=240): Patients who have not administered any SGLT2 inhibitors more than 60 months before enrollment.
3) Age of between 20 and 75 years.
4) Any sexes
5) Outpatients
6) Willingness to provide informed consent
Key exclusion criteria
Patients with any of the following will be excluded:
1)Patients administered any SGLT2 inhibitors except for ipragliflozin during 24 months after index date.
2)Patients who administered ipragliflozin inadequately.
3) Patients who had previous history of malignancy within 5 years before enrollment or 2 years before/after index date.
4) Alcohol abuse or alcohol consumption > 20g per day
5) Patients who underwent hemodialysis within 5 years before enrollment or 2 years before/after index date.
6) Patients who had a history of pregnancy and/or breastfeeding within 5 years before enrollment or 2 years before/after index date.
7) Willingness not to provide informed consent.
8) Judged inappropriate to participate by the study investigator.
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Horie |
Organization
Nagasaki University Hospital
Division name
Endocrinology and Metabolism
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197262
horie@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Horie |
Organization
Nagasaki University Hospital
Division name
Endocrinology and Metabolism
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197262
Homepage URL
horie@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hokkaido University
Hyogo College of Medicine
Showa University School of Medicine
Kobe University Graduate School of Medicine
Minami Diabetes Clinical Research Center
Kumamoto Central Hospital
Sasebo City General Hospital
Sasebo Chuo Hospital
National Hospital Organization Nagasaki Medical Center
Midori Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
0958197262
horie@nagasaki-u.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
| 2023 | Year | 06 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is two-arm, multicenter, open-label (non-blinded), observational cohort study to assess the association between an adjunctive treatment of ipragliflozin and longitudinal kidney function in Japanese patients with T1D.
Management information
Registered date
| 2022 | Year | 04 | Month | 08 | Day |
Last modified on
| 2022 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054091
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