RESTORE-nephropathy study

JRCT ID: jRCTs031190185

Registered date:14/01/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 14/01/2020
• Target sample size: 47
• Study type: Interventional

Intervention(s)

Administer tofogliflozin to the subjects for 24 weeks.
Then, tofogliflozin is withdrawn for 12 weeks of washout period.
After the washout period, tofogliflozin is re-administered to the study patients for 24 weeks.

Outcome(s)

• Primary Outcome: Change in urinary albumin (to creatinine ratio, UACR) from baseline to week 60

Secondary Outcome

1. Change in urinary albumin (to creatinine ratio, UACR) from baseline to week 24
2. Change in urinary albumin (to creatinine ratio, UACR) from week 24 to week 60
3. Change in urinary albumin (to creatinine ratio, UACR) from week 24 to week 36
4. Change in following endpoints from baseline to week 12 (comparison before and after administration)
5. Change in following endpoints from baseline to week 24 (comparison before and after administration)
6. Change in following endpoints from baseline to week 36 (comparison before and after administration)
7. Change in following endpoints from baseline to week 48 (comparison before and after administration)
8. Change in following endpoints from baseline to week 60 (comparison before and after administration)
9. Change in following endpoints from week 24 to week 36 (comparison before and after washout)
10. Change in following endpoints from week 36 to week 48 (comparison before and after re-administration)
11. Change in following endpoints from week 36 to week 60 (comparison before and after re-administration)
12. Change in following endpoints from week 24 to week 60 (comparison after administration/re-administration)
- Body weight, BMI, waist circumference
- Blood pressure (sitting position, office blood pressure)
- Glucose metabolism-related (HbA1c)
- Renal function-related (plasma creatinine, eGFR*)
- Biochemical test indexes (BUN, Na, K, urate, AST, ALT)
- Lipid biomarkers (TC, HDL-C, LDL-C)
- Blood counts (white blood cell count [WBC], red blood cell cound [RBC], hemoglobin [Hb], hematocrit [Ht], platelet [PLT], mean corpuscular volume [MCV*], mean corpuscular hemoglobin [MCH*], mean corpuscular hemoglobin concentration [MCHC*], red cell distribution width [RDW])
- Urinary qualitative examinations
- Fractionated metanephrines (metanephrine, normetanephrine)
- Urinary L-FABP
* calculated by formula
13. Frequency of disease or the like or adverse event

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tanaka Masami
• Secondary Sponsor: Itoh Hiroshi,Hayashi Kaori
• Source(s) of Monetary Support: Kowa Co., Ltd.