JPRN-jRCT1071220115
Recruiting
未知
Real-world study on the efficacy of an adjunctive use of ipragliflozin for prevention of chronic kidney disease in patients with type 1 diabetes - IPRA-CKD
Horie Ichiro0 sites360 target enrollmentMarch 14, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Horie Ichiro
- Enrollment
- 360
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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