Chronic Kidney Disease
Conditions
Brief summary
The purpose of this study is to evaluate the Efficacy and Safety of Fimasartan in patients with hypertensive diabetic chronic kidney disease.
Detailed description
The randomized subjects will take the investigational product (Fimasartan or Losartan) corresponding to each treatment group for 24 weeks. After that, all subjects will take Fimasartan for additional 120 weeks in an open-label, 2-parallel group study conducted with 2 groups in accordance with the blood pressure control criteria.
Interventions
DRUGFimsartan 60mg~120mg
Standard BP control group (SBP \< 140 mmHg). In case of patients with blood pressure that cannot be controlled to the targeted level during the entire clinical study period, the dose of study drug is increased or other antihypertensive drugs are administered concomitantly.
DRUGLosartan 50mg~100mg
Standard BP control group (SBP \< 140 mmHg). In case of patients with blood pressure that cannot be controlled to the targeted level during the entire clinical study period, the dose of study drug is increased or other antihypertensive drugs are administered concomitantly.
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female adults aged 19 years or older 2. Blood pressure: Mean blood pressure is as below at screening. * For treatment-naïve patients: 140 mmHg ≤ SBP \< 180 mmHg and DBP \< 110 mmHg * For patients who are taking ACEI or ARB: 130 mmHg ≤ SBP \< 180 mmHg and DBP \< 110 mmHg 3. eGFR: ≥ 30 ml/min/1.73 m2 within the past 6 months 4. Albuminuria (ACR) excretion volume: Meets one or more of the following conditions * ACR \> 300 mg/g (or mg/day) within the past 12 months * There are at least two results of 30 ≤ ACR ≤ 300 mg/g (or mg/day) within the past 12 months and the interval between the two test is at least 12 weeks. 5. Patients with diabetes 6. Voluntarily provided a written consent to participate 7. Able to understand this study, be cooperative in the execution of the study
Exclusion criteria
1. Severe hypertension with mean SBP ≥ 180 mmHg or DBP ≥ 110 mmHg 2. Orthostatic hypotension with symptoms 3. Insulin dependent diabetes mellitus or uncontrolled diabetes mellitus 4. Patients on dialysis, patients with clinically significant cardiac and hepatic diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare and evaluate the rate of change in albuminuria | 6months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time to the first occurrence of the cardiovascular composite endpoint in accordance with the blood pressure control criteria | 36months | Cardiovascular composite endpoint: Occurrence of myocardial infarction (MI) and stroke; hospitalization due to heart failure and unstable angina; coronary revascularization and peripheral revascularization; and all caused death |
| The time to the first occurrence of the renal composite endpoint in accordance with the blood pressure control criteria | 36months | Renal composite endpoint: The time point where the reduction in eGFR of ≥ 50% compared with baseline eGFR; the time where the progression to ESRD is confirmed (in case of the initiation of long-term dialysis or renal transplantation); all caused death |
| The time to the first occurrence of the combined cardiovascular and renal composite endpoint in accordance with the blood pressure control criteria | 36months | — |
Countries
South Korea
Outcome results
None listed