Japanease

Mar. 25, 2020

May. 21, 2020

jRCTs071190054

Program of ipragliflozin for endothelial dysfunction in chronic kidney disease and type 2 diabetes: a multicenter, randomized-controlled, open-label trial (PROCEED)

Program of ipragliflozin for endothelial dysfunction in chronic kidney disease and type 2 diabetes: a multicenter, randomized-controlled, open-label trial (PROCEED)

Node Koichi

Saga University Hospital

1-1, 5-chome, Nabeshima, Saga-shi

+81-952-34-2364

node@cc.saga-u.ac.jp

Tanaka Atsushi

Saga University Hospital

1-1, 5-chome, Nabeshima, Saga-shi

+81-952-34-2364

tanakaa2@cc.saga-u.ac.jp

Mar. 26, 2020

110

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

none

1. Adults with >= 30 years
2. T2D with 6.0 % <= HbA1c < 9.0 %
3. CKD with (i) [30 <= estimated glomerular filtration ratio (eGFR) < 60] or (ii) [albuminuria >= 30 mg/g CR]
4. RHI < 2.10 at pre-testing RH-PAT within 3 months prior to randomization (RHI >= 2.10 is recognized as normal endothelial function)
5. The patient provided written informed consent to participate in the study

1. Type 1 diabetes
2. History of clinically apparent atherosclerotic cardiovascular diseases, such as coronary artery disease, stroke, peripheral artery disease, symptomatic carotid artery stenosis
3. Chronic atrial fibrillation
4. History of severe ketosis, diabetic coma, or precoma attack <= 6 months prior to informed consent
5. Severe renal dysfunction (eGFR < 30 mL/min/1.73m2 or undergoing dialysis)
6. Patients received SGLT2 inhibitors within 3 month before informed consent
7. Patients who have changed the type or dose of antidiabetic drugs within 3 months before informed consent
8. Hypersensitivity to ipragliflozin or other SGLT2 inhibitors
9. Symptomatic hypotension, or systolic blood pressure < 90 mm Hg
10. Patients with severe infection or trauma at screening
11. Patients in perioperative period around screening
12. Polysystic kidney disease, lupus nephritis, or ANCA-related vasculitis
13. Pregnant or suspected pregnancy
14. Considered inappropriate for the study by investigators due to other reasons, such as malignancy and suspected poor compliant with clinic visits or prescribed medication

30age old over
No limit

Both

Patients with Type 2 diabetes and established CKD

1) Ipuragliflozin group:
Participants who are assigned to the ipragliflozin group orally receive ipragliflozin 50 mg once daily in addition to their background medical therapy for diabetes. If the personalized goal is not achieved, the dose of ipragliflozin can be increased by the investigators to 100 mg once daily.
Control group: Participants who are assigned to the control group continue to receive their background medical therapy for diabetes.
2) In addition to the blood sampling performed in an usual medical care, an additional blood sample of 6 mL/visit for plasma biomarker measurements are further collected at baseline and at 24 weeks (or at discontinuation) (Total 12 mL).

The change amount in RHI automatically calculated by RH-PAT device from baseline to 24 weeks or at discontinuation of the treatment

1. The rate of change in RHI automatically calculated by RH-PAT device from baseline to 24 weeks or at discontinuation of the treatment
2. Prevalence of patients whose RHI substantially increase (LnRHI >15%) from baseline to 24 weeks or at discontinuation of the treatment
3. Prevalence of patients whose RHI recover within normal range (>= 2.10) at 24 weeks
4. Prevalence of patients whose RHI recover within normal range (>= 2.10) or substantially increase (LnRHI >15%) from baseline to 24 weeks or at discontinuation of the treatment
5. Prevalence of patients whose RHI substantially decrease (LnRHI >15%) from baseline to 24 weeks or at discontinuation of the treatment

Recruiting

Astellas Pharma Inc.
Not applicable
Saga University Clinical Research Review Board
5-1-1, Nabeshima, Saga-City, Saga, Japan, Saga

+81-952-34-3357

crb@mail.admin.saga-u.ac.jp
Approval

Mar. 11, 2020