EX-DKD study

JRCT ID: jRCTs061190027

Registered date:27/12/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hypertensive patients with diabetic kidney disease
• Date of first enrollment: 25/02/2020
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Esaxerenone is given orally once daily. The initial daily doses will be started at 1.25 mg and titrated to 2.5 mg or 5 mg depending on the patient's condition.

Outcome(s)

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

Secondary Outcome

1. Efficacy
1) Change from baseline in blood pressure (office BP and home BP[bedtime]: SBP, DBP) in the sitting position
2) Trend 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 from baseline in CAVI
6) PD markers (PAC, PRA), blood and urine markers (Na,K,Creatinine,protein/creatinine ratio, NT-proBNP, L-FABP, NAG, beta2-MG, AGT, 8-OHdG)
2. Safety
1) Adverse ebents, Laboratory Assessment, Vital Signs, 12-lead ECG
2) Ratio of change of eGFR
3) Percentage of study subjects with serum potassium levels:5.5 mEq/L or more, 6.0 mEq/L or more

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1)Subjects aged 20 to 85 years at informed consent
2)Patients with type 2 diabetes and HbA1c < 9.0%
3)UACR < 30 mg/gCr, or 30 =< UACR < 1,000 mg/gCr
4)Patients with 30 mL/min/1.73 m2 =< eGFRcreat < 60 mL/min/1.73 m2
5)Patients treated with ACEi or ARB, or, ACEi or ARB + CCB
6)Subjects with hypertension (Office blood pressure: 130 mmHg =< Sitting SBP < 180 mmHg and/or 80 mmHg =< Sitting DBP < 110 mmHg
7)Patients who are able to measure home BP

Exclude criteria

1)Secondary hypertension or malignant hypertension
2)Patients with type 1 diabetes
3)Patients with diabetes due to other specific mechanisms or diseases (Pancreatic exocrine disease, endocrine disease, etc.)
4)Patients diagnosed with non-diabetic nephropathy, AND, whose prescription for steroid or immunosuppressive medication had been modified within 3 months prior to obtaining the signed informed consent, OR, will have their medication adjusted within the next 4 months (e.g. glomerulonephritis, lupus nephritis).
5)Patients with nephrotic syndrome and active nephritis
6)Patients with rapid exacerbation of kidney disease (serum Cr level increased by 50% or more)
7)Patients with comorbidity or history of orthostatic hypotension
8)Patients with a history of serious adverse events to esaxerenone, spironolactone, eplerenone, RA inhibitors or Ca antagonists
9)Hyperkalemia patients, patients whose serum potassium level exceeds 5.0 mEq/L, etc.
10)Patients who are or will be participating in clinical trials with intervention
11)Pregnant, possibly pregnant, breast-feeding or planning to become pregnant during the study
12)Patients whose Ankle-Brachial-Index is =< 0.9 and with symptoms caused by Arteriosclerosis obliterans
13)Patients with cerebrocardiovascular disease
14)Patients with severe liver dysfunction (liver failure, cirrhosis, etc.)
15)Patients diagnosed with life expectancy within one year due to some disease
16)Patients with a history of serious drug allergies
17)Patients who are inappropriate for this study judged by their primary physicians because of some reasons

Related Information

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