RESTORE-nephropathy study

Not Applicable

• Conditions: Type 2 diabetes mellitus; Diabetes Mellitus, Type 2; D003924

• Registration Number: JPRN-jRCTs031190185
• Lead Sponsor: Tanaka Masami

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Patients who meet all of the following criteria are included in this study:
1. Patients with type 2 diabetes mellitus whose HbA1c is 7.0% or higher and less than 9.0% when giving their consent
2. Patients who did not change antidiabetic agents (including usage and dosage of them) within 12 weeks before consenting. The changes in the usage and dosage of insulin are allowed.
3. Patients with stage 2-3 diabetic nephropathy
4. Patients aged 20 years or older and younger than 75 years when giving their consent
5. Patients who give their written consent form to participate in the study

Exclusion Criteria

Patients who fall into any of the following criteria are excluded from participating in the study.
1. Patients with type 1 diabetes mellitus or secondary diabetes
2. Patients with history of SGLT2 inhibitor use
3. Patients who started to use or changed dose of ACE inhibitors or ARB within 3 months before giving their consent
4. Patients with contraindicated condition to use the study drug
5. Patients with history of hypersensitivity against the study drug
6. Patients with history of stroke (patients who have stable symptoms and no recurrence can be excluded.)
7. Patients who are pregnant, breastfeeding, possibly pregnant, or planning to be pregnant
8. Patients with urinary tract infection or genital infection to be treated
9. Patients with dehydration (patients who complain to have any symptoms of dehydration)
10. Patients with malignant tumor or history of malignant tumor (patients who are not currently being treated for a malignant tumor without recurrence and those who can be expected not to have any recurrence during the study period can be included.)
11. Patients with other conditions that the investigator/researcher thinks inappropriate to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in urinary albumin (to creatinine ratio, UACR) from baseline to week 60