Skip to content

Clinical study to clarify the effect of sacubitril valsartan on diabetic kidney disease

A prospective, non-blinded, comparative intervention study to explore the protective effects of sacubitril valsartan on diabetic kidney disease

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031240742
Enrollment
32
Registered
2025-03-25
Start date
2025-03-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Kidney Disease Diabetes, Kidney disease

Interventions

Take 200 mg of Sacubitril/Valsartan once a day.

Sponsors

Teramoto Naoya
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Comparison of changes in the urinary albumin/creatinine ratio between groups at 0 and 28 weeks

Secondary

MeasureTime 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

Public ContactNaoya Teramoto

Chiba University Hospital

ayaa3936@chiba-u.jp+81-432227171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026