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Renal Protective Effect of Esaxerenone in CKD Patients with Hypertension

The Efficacy of Esaxerenone for Chronic Kidney Disease Patients with Uncontrolled Hypertension

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1061230053
Enrollment
20
Registered
2023-08-28
Start date
2024-04-10
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

Chronic kidney disease, Hypertension CKD, Hypertension, Proteinurira, Esaxerenone, ARB

Interventions

Esaxerenone add-on to ARB
Esaxerenone, ARB

Sponsors

Masaki Takao
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 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

Exclusion criteria

Exclusion criteria: 1. Patients with eGFR (mL/min/1.73m2) 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

Design outcomes

Primary

MeasureTime frame
Percent reduction in UPCR at 12 weeks post treatment compared to enrollment

Secondary

MeasureTime frame
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

Contacts

Public ContactAkira Takahashi

Hiroshima University Hospital

takaha4a@hiroshima-u.ac.jp+81-82-257-1506

Outcome results

None listed

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