Chronic Kidney DiseasePhase 3NCT02620306
A Randomized, Double-blind, Active Control, Parallel Group, Titration, Multicenter Study to Evaluate the Efficacy and Safety of Fimasartan
A Phase 3 study testing Fimsartan 60mg~120mg and Losartan 50mg~100mg in people with Chronic Kidney Disease, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the Efficacy and Safety of Fimasartan in patients with hypertensive diabetic chronic kidney disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Fimsartan 60mg~120mg and Losartan 50mg~100mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Feb 2016to 11 May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults aged 19 years or older
- 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
- eGFR: ≥ 30 ml/min/1.73 m2 within the past 6 months
- Albuminuria (ACR) excretion volume: Meets one or more of the following conditions
Show all 11Show fewer
- 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.
- Patients with diabetes
- Voluntarily provided a written consent to participate
- Able to understand this study, be cooperative in the execution of the study
Who cannot join
- Severe hypertension with mean SBP ≥ 180 mmHg or DBP ≥ 110 mmHg
- Orthostatic hypotension with symptoms
- Insulin dependent diabetes mellitus or uncontrolled diabetes mellitus
- Patients on dialysis, patients with clinically significant cardiac and hepatic diseases
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the Efficacy and Safety of Fimasartan in patients with hypertensive diabetic chronic kidney disease.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Fimsartan 60mg~120mg, Losartan 50mg~100mg
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fimsartan 60mg~120mgDrug
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~120mgDrug
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~100mgDrug
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~100mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Fimasartan(A) | Experimental | Not described Receives: Drug: Fimsartan 60mg~120mg |
| Fimasartan(B) | Experimental | Not described Receives: Drug: Fimsartan 60mg~120mg |
| Losartan(A) | Active comparator | Not described Receives: Drug: Losartan 50mg~100mg |
| Losartan(B) | Active comparator | Not described Receives: Drug: Losartan 50mg~100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare and evaluate the rate of change in albuminuria
Measured: 6months
Secondary outcomes (3)
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
Measured: 36months
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
Measured: 36months
The time to the first occurrence of the combined cardiovascular and renal composite endpoint in accordance with the blood pressure control criteria
Measured: 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study start11 Feb 2016
- Primary completion23 Dec 2019
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620306
- Sponsor's protocol ID
- BR-FMS-CT-303
- Status last verified
- May 2021
- First submitted
- 1 Dec 2015
- Last updated
- 25 May 2022
- Results posted
- No
Publications
Park CH, Hong SJ, Kim SG, Shin SJ, Kim DK, Lee JP, Han SY, Lee S, Won JC, Kang YS, Park J, Han BG, Na KR, Hur KY, Kim YJ, Park S, Yoo TH. Blood pressure control in diabetic kidney disease: a post-hoc analysis of the FANTASTIC trial. Clin Hypertens. 2024 Aug 1;30(1):20. doi: 10.1186/s40885-024-00280-x.
PubMed 39085979Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.
PubMed 38682786Kim JY, Son JW, Park S, Yoo TH, Kim YJ, Ryu DR, Chin HJ. FimAsartaN proTeinuriA SusTaIned reduCtion in comparison with losartan in diabetic chronic kidney disease (FANTASTIC): study protocol for randomized controlled trial. Trials. 2017 Dec 29;18(1):632. doi: 10.1186/s13063-017-2375-8.
PubMed 29284530
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active Control, Parallel Group, Titration, Multicenter Study to Evaluate the Efficacy and Safety of Fimasartan
- ClinicalTrials.gov ID
- NCT02620306
- Acronym / sponsor ID
- BR-FMS-CT-303
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2016 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fimasartan(A) | Experimental | Drug: Fimsartan 60mg~120mg |
| Fimasartan(B) | Experimental | Drug: Fimsartan 60mg~120mg |
| Losartan(A) | Active comparator | Drug: Losartan 50mg~100mg |
| Losartan(B) | Active comparator | Drug: Losartan 50mg~100mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male and female adults aged 19 years or older
- Blood pressure: Mean blood pressure is as below at screening.
- eGFR: ≥ 30 ml/min/1.73 m2 within the past 6 months
- Albuminuria (ACR) excretion volume: Meets one or more of the following conditions
- Patients with diabetes
Key exclusion criteria (4 listed)
- Severe hypertension with mean SBP ≥ 180 mmHg or DBP ≥ 110 mmHg
- Orthostatic hypotension with symptoms
- Insulin dependent diabetes mellitus or uncontrolled diabetes mellitus
- Patients on dialysis, patients with clinically significant cardiac and hepatic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fimsartan 60mg~120mgStandard 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. | Drug | Fimasartan(A) |
| Fimsartan 60mg~120mgStrict 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. | Drug | Fimasartan(B) |
| Losartan 50mg~100mgStandard 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. | Drug | Losartan(A) |
| Losartan 50mg~100mgStrict 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. | Drug | Losartan(B) |
Primary outcome
To compare and evaluate the rate of change in albuminuria
Time frame: 6months
3 secondary outcomes
The time to the first occurrence of the cardiovascular composite endpoint in accordance with the blood pressure control criteria
Time frame: 36months
The time to the first occurrence of the renal composite endpoint in accordance with the blood pressure control criteria
Time frame: 36months
The time to the first occurrence of the combined cardiovascular and renal composite endpoint in accordance with the blood pressure control criteria
Time frame: 36months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Derived from this study: PubMed 39085979Park CH, Hong SJ, Kim SG, Shin SJ, Kim DK, Lee JP, Han SY, Lee S, Won JC, Kang YS, Park J, Han BG, Na KR, Hur KY, Kim YJ, Park S, Yoo TH. Blood pressure control in diabetic kidney disease: a post-hoc analysis of the FANTASTIC trial. Clin Hypertens. 2024 Aug 1;30(1):20. doi: 10.1186/s40885-024-00280-x.
- Derived from this study: PubMed 38682786Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.
- Derived from this study: PubMed 29284530Kim JY, Son JW, Park S, Yoo TH, Kim YJ, Ryu DR, Chin HJ. FimAsartaN proTeinuriA SusTaIned reduCtion in comparison with losartan in diabetic chronic kidney disease (FANTASTIC): study protocol for randomized controlled trial. Trials. 2017 Dec 29;18(1):632. doi: 10.1186/s13063-017-2375-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fimsartan 60mg~120mg and Losartan 50mg~100mg in people with Chronic Kidney Disease, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare and evaluate the rate of change in albuminuria (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02620306, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.