Patients with chronic kidney disease (CKD) whose blood pressure is not under control
Conditions
Interventions
Intervention group (ARNI group): First, there will be an observation period (1-3 months) during which patients will switch from their original angiotensin II receptor blocker (ARB) to 20-40 mg olmesa
Sponsors
International University of Health and Welfare Narita Hospital
Department of Nephrology, International University of Health and Welfare, Department of Nephrology and Hypertension, Kameda General Hospital, Department of Internal Medicine, Tokyo Dental University Ichikawa General Hospital, Department of Nephrology, Endocrinology and Diabetes, Tokyo Bay Urayasu Ichikawa Medical Center, and Department of Nephrology, Gyotoku General Hospital.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following conditions must be met by outpatients attending the Department of Nephrology, International University of Health and Welfare Narita Hospital, Department of Nephrology, International University of Health and Welfare Hospital, Department of Nephrology and Hypertension, Kameda General Hospital, Department of Internal Medicine, Tokyo Dental University Ichikawa General Hospital, Department of Nephrology, Endocrinology and Diabetes, Tokyo Bay Urayasu Ichikawa Medical Center, and Department of Nephrology, Gyotoku General Hospital. Patients whose eGFR is 15-60 mL/min/1.73m2 (CKD G3a-4) based on blood sampling within 3 months. Patients on RAS inhibitors but with poor blood pressure control according to the antihypertensive targets of "The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019)". Specifically, for patients aged 75 years or older, patients with bilateral carotid stenosis or main cerebral artery occlusion, and patients without proteinuria (<0.15 g/gCr), the office blood pressure and home blood pressure should be 140/90 mmHg and 135/85 mmHg or higher, respectively; for other patients, the office blood pressure and home blood pressure should be 130/80 mmHg and 125/75 mmHg or higher, respectively. Patients who have not taken ARNI or TZD for 3 months. Patients who have been fully informed about the study and who have given written consent of their own free will.
Exclusion criteria
Exclusion criteria: In consideration of the impact on safety evaluation, the following exclusion criteria are used Patients with marked hypertension (systolic blood pressure >180 or diastolic blood pressure >110 mmHg sustained). Patients with symptomatic coronary artery disease or cerebrovascular disease within 3 months. Patients with uncontrolled heart failure (NYHA III or higher). Patients with arrhythmia with severe symptoms or fatal arrhythmia. Patients with acute kidney injury. Patients with nephrotic syndrome. Patients with terminal cancer who are expected to live less than one year. Other patients who are deemed inappropriate as research subjects by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the rate of decline in kidney function. Estimated glomerular filtration rate (eGFR) slope during the 12-month treatment period is calculated by linear regression from eGFR (both from serum creatinine and from serum cystatin C) measured every 1 to 3 months. The eGFR slope for the 12-month treatment period is calculated by linear regression. We will also compare the trend of eGFR in the two groups using a linear mixed model or a generalized linear mixed model with fixed effects of time period and various confounding factors. | — |
Secondary
| Measure | Time frame |
|---|---|
| Antihypertensive effects [office and home (systolic and diastolic) blood pressure at the end of the 12-month treatment period.of the 12-month treatment period between the two groups, as well as the degree of blood pressure reduction from baseline and blood pressure trends using a linear mixed model (as with eGFR)]. Body weight and body mass index (will be compared in the same way as blood pressure) N-terminal fragment of brain natriuretic peptide precursor (NT-proBNP) (at the end of the 12-month treatment period will be compared between the two groups, as well as the degree of NT-proBNP change compared to baseline) In addition to urine protein and urine albumin, liver-type fatty acid binding protein (L-FABP) and markers of tubular damage such as beta2-microglobulin and N-acetylglucosaminidase (NAG) (mainly at the end of the 12-month treatment period) Urinary electrolytes such as sodium, potassium, chloride, creatinine and urea nitrogen Serum sodium, potassium, chloride, uric acid, triglycerides and other parameters related to lipid and glucose metabolism | — |
Countries
Japan
Contacts
Public ContactKiyotaka Uchiyama
International University of Health and Welfare Narita Hospital Department of Nephrology
Outcome results
None listed