Diabetic Kidney Disease Diabetes, Kidney disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: The following conditions must all be met 1.Patients who are 18 years of age or older at the time of obtaining consent 2.Patients who have been diagnosed with type 2 diabetes and have a u-Alb of 30 micro gram/mgCre or higher within 6 months at the time of obtaining consent 3.Patients who have been treated with ARB (olmesartan 20 mg/day) for at least 4 weeks at the time of obtaining consent 4. Patients with an eGFR of 30 or more 5. Patients with a K of 5.4 mmol or less 6. Patients who have given their written consent freely and of their own accord after being fully informed of the study and fully understanding it
Exclusion criteria
Exclusion criteria: The following patients are not eligible for the study 1) Patients who are already using an MR antagonist or direct renin inhibitor 2) Patients with a systolic blood pressure of 180 mmHg or higher or a systolic blood pressure of less than 110 mmHg in the examination room on the day consent is obtained 3) Patients with a history of glomerulonephritis 4) Patients with a history of angioedema 5) Patients with a history of hypersensitivity to sacubitril/valsartan 6) Patients with severe hepatic dysfunction (Child-Pugh classification C) 7) Patients who are pregnant, may become pregnant, are within 28 days of giving birth, or are breastfeeding 8) Patients who the principal investigator or sub-investigator deems unsuitable for the safe conduct of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of changes in the urinary albumin/creatinine ratio between groups at 0 and 28 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes for efficacy Comparison of changes in the urinary albumin/creatinine ratio between groups at 0 and 12 weeks Comparison of changes in the eGFR, urinary Beta2-microglobulin, NAG levels, serum Na, K, Cl levels, urinary Na, K levels, serum HbA1c, blood glucose levels at any time , plasma renin activity (PRA), plasma aldosterone concentration (PAC), NT-proBNP, systolic blood pressure, diastolic blood pressure, serum uric acid level, and urinary L-FABP level Secondary outcomes for safety Frequency of adverse events, presence or absence of hypotensive symptoms | — |
Contacts
Chiba University Hospital