Renal Protective Effect of Esaxerenone in CKD Patients with Hypertension

JRCT ID: jRCT1061230053

Registered date:28/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic kidney disease, Hypertension
• Date of first enrollment: 28/08/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Esaxerenone add-on to ARB

Outcome(s)

• Primary Outcome: Percent reduction in UPCR at 12 weeks post treatment compared to enrollment
• Secondary Outcome: Change in eGFR, Change in systolic and diastolic blood pressure, Percentage of patients with improved UPCR rank at 12 weeks post treatment compared to enrollment, Percentage of patients with improved UPCR at 12 weeks post treatment compared to enrollment, Change in NT-proBNP, serum K levels, safety assessment

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1. Patients whose written consent has been obtained from the patient
2. Patients of any gender, aged between 18 and 85 years at the time of consent
3. Patients with poorly controlled hypertension (systolic blood pressure greater than 130 mmHg and/or diastolic blood pressure greater than 80 mmHg at examination within 4 weeks prior to enrollment)
4. Patients with eGFR (mL/min/1.73m2) >30 and <60 and abnormal proteinuria (>0.15 g/gCr) prior to enrollment
5. Patients who have been taking a dose of antihypertensive medication (ARB: losartan 25-50 mg, irbesartan 50-100 mg, telmisartan 40 mg, olmesartan 10-20 mg, or azilsartan 20 mg) continuously for at least 4 weeks without change
6.Ppatients who are able to continuously measure blood pressure with a home blood pressure monitor

Exclude criteria

1. Patients with eGFR (mL/min/1.73m2) <30 prior to enrollment
2. Patients with UPCR >3.5 g/gCr prior to enrollment
3. Patients with hypersensitivity to esaxerenone
4. Patients with hyperkalemia or serum potassium level > 5.0 mEq/L at the start of treatment with this drug
5. Patients receiving potassium retaining diuretics (spironolactone, triamterene, potassium canrenoate), aldosterone antagonists (eplerenone) or potassium preparations (potassium chloride, potassium gluconate, potassium aspartate, potassium iodide, potassium acetate)
6. Pregnant, lactating, possibly pregnant or planning to become pregnant
7. Patients undergoing anticancer therapy
8. Patients who are unable to comply with their medication regimen
9. Other patients who are judged by the principal investigator or subinvestigator to be inappropriate as subjects for this study

Related Information

• Primary Sponsor: Masaki Takao