EAGLE-DH study

JRCT ID: jRCTs031200273

Registered date:25/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hypertension with diabetes
• Date of first enrollment: 07/01/2021
• Target sample size: 90
• Study type: Interventional

Intervention(s)

Orally administer Esaxerenone once a day according to package insert. Start administration of Esaxerenone 2.5mg and if the effect is insufficient, the dose can be increased to 5 mg.
Patients with moderate renal dysfunction (eGFRcreat is 30 or more and less than 60 mL.min/1,73m2) and albuminuria or diabetes with proteinuria start administration of Esaxerenone 1.25 mg, and the dose is increased to 2.5 mg after 4th week of the administration period, depending on the condition of the patient such as serum potassium level. If the effect is insufficient, the dose can be increased to 5 mg.

Outcome(s)

• Primary Outcome: Change form baseline in blood pressure [home BP(before early morning medication): systolic BP, diastolic BP]in the sitting position

Secondary Outcome

1, Efficacy
1) Change form baseline in blood pressure [office BP and home BP (bedtime): systolic BP, diastolic BP]in the sitting position
2) Transition of change from baseline in blood pressure [office BP and home BP (before early morning medication and bedtime): systolic BP, diastolic BP and mean BP]in the sitting position
3) Achievement ratio of target BP levels
4) Change from baseline in UACR
5) Change form baseline in serum NT-proBNP and CRP
6) Change form baseline in HbA1c
7) Change from baseline in plasma renin activity, plasma aldosterone concentration, and aldosterone-renin ratio
8) Change from baseline in urinary biomarker (Na, K, Na/K ratio, L-FABP, NAG, Beta2-MG, 8-OHdG)

2, Safety
1) Incidence of adverse events
2) Transition and amount of change in eGFRcreat
3) Percentage of study subjects with serum potassium levels:5.5 mEq/L or more, 6.0 mEq/L or more
4) Change in serum potassium
5) Changes in pulse rate, amount of change

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients aged 20 years or older
2) Patients with type 2 diabetes
3) Patients treated oral hypoglycemic drugs (one SGLT2 inhibitor, one SGLT2 inhibitor + one other oral hypoglycemic drug combination, or one SGLT2 inhibitor + two other oral hypoglycemic drug combination) at a fixed dosage
4) Patients treated basal antihypertensive drugs (one RAS inhibitor, one Ca channel blocker, or one RAS inhibitor + one Ca channel blocker)
5) Patients with hypertension (early morning home blood pressure [BP]: =>125 mmHg and <160 mmHg of systolic blood pressure and/or =>75 mmHg and <100 mmHg of diastolic blood pressure)
6) Patients whose eGFRcreat (mL/min/1.73 m2) is 30 or more
7) Patients who can measure home blood pressure

Exclude criteria

1) Patients diagnosed with secondary hypertension or patients with malignant hypertension
2) Patients treated insulin and GLP-1 receptor agonist
3) Patients with nephrotic syndrome
4) Hyperkalemia patients, patients whose serum potassium level exceeds 5.0 mEq/L
5) Patients with any cerebro-cardiovascular diseases
6) Patients had NYHA class IV
7) Patients treated contraindication medicine specified in this study within 4 weeks prior to enrollment
8) Patients with severe liver dysfunction (liver failure, cirrhosis, etc.)
9) Patients diagnosed with life expectancy within one year due to some disease
10) Patients with a history of serious drug allergy
11) Pregnant, possibly pregnant, breast-feeding or planning to become pregnant
12) Patients who are inappropriate for this study judged by their primary physicians

Related Information

• Primary Sponsor: Motoki Hirohiko
• Source(s) of Monetary Support: Daiichi Sankyo.Co., Ltd.