Study on the efficacy of ipragliflozin for prevention of chronic kidney disease in type 1 diabetes

JRCT ID: jRCT1071220115

Registered date:14/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 1 diabetes
• Date of first enrollment: 14/03/2023
• Target sample size: 360
• Study type: Observational

Outcome(s)

• Primary Outcome: 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: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Horie Ichiro
• Source(s) of Monetary Support: Astellas Pharma Inc.