Renal Protective Effect of Esaxerenone in CKD Patients with Hypertensio

Phase 2

Recruiting

• Conditions: Chronic kidney disease, Hypertension; CKD, Hypertension, Proteinurira, Esaxerenone, ARB

• Registration Number: JPRN-jRCT1061230053
• Lead Sponsor: Masaki Takao

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-28
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion 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) at least twice within 6 weeks 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

Exclusion Criteria

1. Patients with eGFR (mL/min/1.73m2) <30 at least once within 6 weeks prior to enrollment
2. Patients with UPCR >3.5 g/gCr at least once within 4 weeks 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified