UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062411 |
|---|---|
| Receipt number | R000071412 |
| Scientific Title | Efficacy of Esaxerenone for VEGF Inhibitor-Associated Hypertension: A Single-Arm Prospective Study |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/30 16:04:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of Esaxerenone for VEGF Inhibitor-Associated Hypertension: A Single-Arm Prospective Study
Acronym
Efficacy of Esaxerenone for VEGF Inhibitor-Associated Hypertension: A Single-Arm Prospective Study
Scientific Title
Efficacy of Esaxerenone for VEGF Inhibitor-Associated Hypertension: A Single-Arm Prospective Study
Scientific Title:Acronym
Efficacy of Esaxerenone for VEGF Inhibitor-Associated Hypertension: A Single-Arm Prospective Study
Region
| Japan |
Condition
Condition
Patients with colorectal cancer and resistant hypertension during VEGF inhibitor therapy
Classification by specialty
| Gastroenterology | Cardiology | Nephrology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in office blood pressure from baseline to Week 12
Key secondary outcomes
- Urinary protein-to-creatinine ratio
- Morning home blood pressure
- Adverse events, including hyperkalemia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be considered eligible:
1) Patients with histologically or clinically diagnosed colorectal cancer.
2) Patients receiving treatment with a VEGF inhibitor, including bevacizumab, ramucirumab, or aflibercept, and who are expected to continue such treatment after enrollment.
3) Patients who developed new-onset hypertension or experienced worsening of pre-existing hypertension after initiation of VEGF inhibitor therapy.
4) Patients who have received either an angiotensin II receptor blocker or a calcium channel blocker as monotherapy at a stable dose for at least 4 weeks before enrollment.
5) Patients whose office blood pressure at enrollment meets either of the following criteria:
- Systolic blood pressure (SBP) of >=130 mmHg and <180 mmHg
- Diastolic blood pressure (DBP) of >=80 mmHg and <110 mmHg
6) Patients in whom the urinary protein-to-creatinine ratio can be assessed before or at enrollment and serially evaluated during the study period.
7) Patients aged 20 years or older at the time of enrollment.
8) Patients who are able to provide written informed consent.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded:
1) Patients with a serum potassium level >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) <30 mL/min/1.73 m2.
3) Patients with severe hepatic impairment, defined as Child-Pugh class C or an equivalent clinical condition.
4) Patients currently receiving a mineralocorticoid receptor antagonist, such as esaxerenone, spironolactone, or eplerenone.
5) Patients with serious cardiovascular disease, including unstable angina, myocardial infarction within the previous 6 months, or heart failure of NYHA class III or higher.
6) Patients with poorly controlled diabetes mellitus, defined as HbA1c >=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 sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kudo |
| Middle name | |
| Last name | Kudo |
Organization
Iwate Medical University Hospital
Division name
Department of Pharmacy
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
TEL
019-613-7111
kenzkudo@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Nihei |
Organization
Iwate Medical University Hospital
Division name
Department of Pharmacy
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
TEL
019-613-7111
Homepage URL
satoru@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate Medical University
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
Tel
019-613-7111
satoru@iwate-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 30 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071412
