Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062411) titled 'Efficacy of Esaxerenone for VEGF Inhibitor-Associated Hypertension: A Single-Arm Prospective Study' on Aug. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - Iwate Medical University
Condition:
Condition - Patients with colorectal cancer and resistant hypertension during VEGF inhibitor therapy
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to evaluate changes in blood pressure following the administration of esaxerenone in patients with colorectal cancer who develop hypertension during vascular endothelial growth factor (VEGF) inhibitor therapy and show an inadequate response to antihypertensive treatment. In addition, the urinary protein-to-creatinine ratio will be assessed to exploratorily investigate the effect of esaxerenone on proteinuria.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Esaxerenone will be administered orally at the usual dosage. Treatment will be initiated in accordance with the approved prescribing information, and the dose will be adjusted as appropriate based on blood pressure, renal function, and serum potassium levels.
Eligibility:
Age-lower limit - 20
years-old
=130 mmHg and =80 mmHg and 5.0 mEq/L at the end of the pre-enrollment observation period.
2) Patients with severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) =8.5%.
7) Patients with a clinically significant psychiatric disorder that is considered likely to interfere with study participation or medication management.
8) Patients who are pregnant, breastfeeding, or may be pregnant.
9) Patients with a history of hypersensitivity to esaxerenone.
Target Size - 20
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 07 Month 13 Day
Date of IRB - 2026 Year 07 Month 22 Day
Anticipated trial start date - 2026 Year 07 Month 23 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071412
Disclaimer: Curated by HT Syndication.
