Real-world study on the efficacy of an adjunctive use of ipragliflozin for prevention of chronic kidney disease in patients with type 1 diabetes
- Conditions
- Type 1 diabetes
- Registration Number
- JPRN-UMIN000047441
- Lead Sponsor
- agasaki University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 360
Not provided
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.