A Randomized, Double-blind, Active Control, Parallel Group, Titration, Multicenter Study to Evaluate the Efficacy and Safety of Fimasartan

Chronic Kidney Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620306
• Other study ID #: BR-FMS-CT-303
• Status: Completed
• Phase: Phase 3
• Start date: February 11, 2016
• Est. completion date: May 11, 2022

Study information

• Verified date: May 2021
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the Efficacy and Safety of Fimasartan in patients with hypertensive diabetic chronic kidney disease.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: May 11, 2022
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Fimsartan 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.
• Fimsartan 60mg~120mg
Strict BP control group (SBP < 130 mmHg). In case of patients with blood pressure that cannot be controlled to the targeted level at each visit during the entire clinical study period, the dose of study drug is increased or other antihypertensive drugs are administered concomitantly.
• Losartan 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.
• Losartan 50mg~100mg
Strict BP control group (SBP < 130 mmHg). In case of patients with blood pressure that cannot be controlled to the targeted level at each visit during the entire clinical study period, the dose of study drug is increased or other antihypertensive drugs are administered concomitantly.

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare and evaluate the rate of change in albuminuria		6months
Secondary	The time to the first occurrence of the cardiovascular composite endpoint in accordance with the blood pressure control criteria	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	36months
Secondary	The time to the first occurrence of the renal composite endpoint in accordance with the blood pressure control criteria	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	36months
Secondary	The time to the first occurrence of the combined cardiovascular and renal composite endpoint in accordance with the blood pressure control criteria		36months