Hypertension with chronic kidney disease
Conditions
Interventions
Irbesartan 200 mg/day and efonidipine 40-60 mg/day (initial dose is 20 mg for elderly patients)
Irbesartan 200 mg/day and cilnidipine 5-10 mg/day
Sponsors
Shinshu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Outpatients and in-patients who give written informed consent. (2) Patients with hypertension and CKD whose blood pressure cannot achieve less than 130/80 mmHg. Patients with persistent proteinuria (>1 g/day) whose blood pressure cannot achieve less than 125/75 mmHg. (3) Patients with diabetes mellitus whose albuminuria cannot achieve less than 30 mg/g. Patients without diabetes mellitus whose proteinuria cannot achieve less than 300 mg/g. (4) Patients under treatment with an ARB except irbesartan and Patients who do not achieve the above-mentioned criteria (2) or (3). (5) Patients with serum Cr≤3.0 mg/dL (patients with eGFR≥40)
Exclusion criteria
Exclusion criteria: (1) Patients who are younger than 20 or older than 80 years. (2) Patients who have renovascular hypertension, primary aldosteronism, Cushing's disease, or pheochromocytoma (3) Patients who had transient ischemic attack or apoplexy within six months prior to enrollment (4) Patients who had unstable angina, acute myocardial infarction, or underwent coronary artery bypass graft or percutaneous coronary intervention within six months prior to enrollment. (5) Patients who have congestive heart failure of NYHA class II or higher (6) Patients who have dissection of aorta or occlusive arterial disease (7) Patients who have HbA1c > 9.0% or uncontrolled diabetes mellitus (8) Patients who are pregnant or have possibility of pregnancy (9) Patients whose levels of AST or ALT are more than 2 times higher than upper normal limits (10) Patients who had nephrotic syndrome within one year prior to enrollment or have nephrotic syndrome (11) Patients who have malignant diseases or collagen diseases (12) Patients in whom irbesartan is contraindicated (13) Patients in whom efonidipine is contraindicated (14) Patients in whom cilnidipine is contraindicated (15) Patients who have previous history of allergy to an ARB or CCB (16) Patients who are taking another hypertensive drug together with an ARB at maximum dosing (17) Patients who were deemed not appropriate to participate in this study by doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Change in aldosterone (2) Change in proteinuria (3) Change in eGFR | — |
Secondary
| Measure | Time frame |
|---|---|
| Change before and after treatment of the following items: (1) BNP and hs-CRP (2) Urinary 8-OHdG | — |
Countries
Japan
Contacts
Public ContactMakoto Higuchi
Shinshu University Hospital Blood Purification Unit and Nephrology
Outcome results
None listed