EX-DKD study

Not Applicable

• Conditions: Hypertensive patients with diabetic kidney disease; DKD, Hypertension

• Registration Number: JPRN-jRCTs061190027
• Lead Sponsor: Wada Jun

Brief Summary

In hypertensive patients with DKD inadequately controlled by RASi or RASi plus CCB, esaxerenone demonstrated a BP-lowering effect and improvement in albuminuria. The beneficial effects were consistent regardless of the severity of albuminuria. Additionaly, esaxerenone can be used safely without clinically relevant serum potassium elevation and eGFR reduction. Esaxerenone may be a suitable antihypertensive treatment option for hypertensive patients with DKD with moderately renal impairment.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-27
• Study Completion: 2021-10-20
• Results First Posted: 2022-09-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 113

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified