Diabetic Kidney DiseaseFINALENCT05086549
An Observation Study to Evaluate the Renoprotective Effect of Fimasartan in Patients With DKD and Proteinuria
An observational study of Diabetic Kidney Disease and Proteinuria, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
This study aims to observe changes in various indicators of renal function, such as proteinuria at different time points: short-term (Week 8), 6 months (Week 26), and a year (Week 52), in patients with DKD and hypertension, who are given antihypertensives containing fimasartan, in an actual clinical environment where… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetic Kidney Disease, Proteinuria, Hypertension,Essential
- How many people
- 360 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Sep 2021to 5 Jun 2023
- Phase
- Observational
- 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
Study population: Patients with diabetic kidney disease and proteinuria (urine ACR of 10 mg/g or higher)
Who may be able to join
- Male and female adults aged 19 or older
- Those who were diagnosed with type 2 diabetes and have been being given stable doses of hypoglycemic agents for 8 weeks or longer
- Those in whom albuminuria was found to meet one of the following criteria two times before the administration of the antihypertensive treatment containing fimasartan (results (baseline values) within 4 weeks before the administration of antihypertensives must be ACR or AER results)
- An albumin/creatinine ratio (ACR) of 10 mg/g or higher or
- An albumin excretion rate (AER) of 10 mg/day or higher or
- A proteinuria/creatinine ratio (PCR) of 70 mg/g or higher or
Show all 12Show fewer
- A urine dipstick result of trace to 1+ or higher
- Those who plan to be given antihypertensive treatment containing fimasartan for essential hypertension or are being given the treatment (in this case, those with an administration period of 6 weeks or lower can be enrolled)
- Those with records of clinical systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 85 mmHg or higher before the antihypertensive treatment containing fimasartan or at the time of the treatment. The following additional criteria shall be applied depending on age and the presence of comorbidities.
- Aged younger than 65: Systolic blood pressure of 130 mmHg or higher or diastolic blood pressure of 80 mmHg or higher shall be applied to those with cardiovascular disease or an ACR or AER of 30 mg/g or higher.
- Aged 65 or older: Regardless of comorbidities, systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher shall be applied.
- Patients who agreed in writing to the Personal Information Collection and Usage Agreement after listening to the explanation of the objective, method, etc. of this observational study
Who cannot join
- Patients who are suspected of or confirmed with secondary hypertension
- Those diagnosed with type 1 diabetes or secondary diabetes
- Patients undergoing kidney dialysis or patients who received kidney transplants or those for whom kidney dialysis or kidney transplants are planned
- If angiotensin converting enzyme inhibitors (ACEI) or renin inhibitors are used in conjunction or are planned to be used in conjunction
- Patients with moderate to severe hepatic dysfunction (ALT and/or AST of over three times the upper limit of normal) or patients with biliary tract obstruction
- Pregnant and breast-feeding women
- Those who were administered with drugs for clinical studies within 12 weeks from the enrollment or those who plan on participating in other clinical studies while participating in this study
- Other subjects who are considered inappropriate to participate in the study by the investigator's decision
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance hospital, Yonsei University Health System
Seoul
About this study
Official title: A Multicenter, Prospective, Observational Study to Evaluate the Renoprotective Effect of Fimasartan in Patients With Diabetic Kidney Disease and Proteinuria
This study aims to observe changes in various indicators of renal function, such as proteinuria at different time points: short-term (Week 8), 6 months (Week 26), and a year (Week 52), in patients with DKD and hypertension, who are given antihypertensives containing fimasartan, in an actual clinical environment where a variety of patient characteristics are reflected.
Read the detailed description
This prospective observational study is conducted in about 5 medical institutions located in Korea, which are equal to or larger than a hospital, and patients with type 2 diabetic kidney disease (proteinuria with an ACR of 10 mg/g or higher), who are being administered or plan to be administered with antihypertensives containing fimasartan for essential hypertension, are enrolled as the subjects. Each of the subjects shall undergo follow-up for about a year (52 weeks). After explaining the purpose, method, scope of information to be collected, and procedure of this study to potential subjects, the investigator shall obtain the written consent for voluntary participation and set the day when the antihypertensive containing fimasartan is administered as the baseline. If the fimasartan-based antihypertensive treatment is already ongoing, only the patients within 6 weeks from the baseline shall be considered as the subjects. In this case, data from between the baseline and the time of the written consent shall be collected retrospectively. This study is an observational study, and the drugs which are administered during the study period and the medical procedures shall be in accordance with the clinical judgment of the investigator. It is a rule that no unnecessary intervention shall be imposed on the subjects by this study protocol.
The scope of data to be collected during this study period is as follows.
- Demographic information
- Disease information (diabetes, hypertension, renal disease, other past medical history and intercurrent diseases)
- Physical measurements (height and weight)
- Clinic blood pressure measurements
- Laboratory test results
- Antihypertensives, hypoglycemic agents, and other concomitant drugs
- Fimasartan-related adverse drug reactions and serious adverse drug reactions
- Death information (if applicable)
- Conditions
- Diabetic Kidney Disease, Proteinuria, Hypertension,Essential
- Keywords
- Fimasartan, Proteinuria
- Medical subject headings
- Diabetic Nephropathies, Proteinuria, Essential Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in albuminuria (urine ACR)
The descriptive statistics (number of subjects, average, standard deviation, median, minimum value, quartile, and maximum value) regarding the rate of change in albuminuria (urine ACR) at the baseline, on Week 8, and on Week 8 compared to the baseline shall be obtained
Measured: Week 8
Secondary outcomes (3)
Quantity of change in albuminuria (urine ACR)
The descriptive statistics (number of subjects, average, standard deviation, median, minimum value, quartile, and maximum value) regarding the quantity of change in albuminuria (urine ACR) at the baseline, on Week 8, and on Week 8 compared to the baseline shall be obtained
Measured: Week 8
Rate of change in albuminuria (urine ACR)
The descriptive statistics (number of subjects, average, standard deviation, median, minimum value, quartile, and maximum value) regarding the rate of change in albuminuria (urine ACR) at each time point, on Week 26 and Week 52 compared to the baseline shall be obtained
Measured: Week 26, Week 52
Rate of change in proteinuria (urine PCR)
The descriptive statistics (number of subjects, average, standard deviation, median, minimum value, quartile, and maximum value) regarding the rate of change in proteinuria (urine PCR) at each time point, on Week 8, Week 26, and Week 52 compared to the baseline shall be obtained
Measured: Week 8, Week 26, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start29 Sep 2021
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MyungSook Hong, Study director, Boryung Pharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086549
- Sponsor's protocol ID
- BR-FMS-OS-407
- Acronym
- FINALE
- Status last verified
- Jul 2023
- First submitted
- 23 Sep 2021
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational Study to Evaluate the Renoprotective Effect of Fimasartan in Patients With Diabetic Kidney Disease and Proteinuria
- ClinicalTrials.gov ID
- NCT05086549
- Acronym / sponsor ID
- FINALE / BR-FMS-OS-407
- Conditions
- Diabetic Kidney Disease, Proteinuria, Hypertension,Essential
- Keywords
- Fimasartan, Proteinuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 21 Oct 2021 (actual)
- 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.
This study aims to observe changes in various indicators of renal function, such as proteinuria at different time points: short-term (Week 8), 6 months (Week 26), and a year (Week 52), in patients with DKD and hypertension, who are given antihypertensives containing fimasartan, in an actual clinical environment where a variety of patient characteristics are reflected.
Detailed description
This prospective observational study is conducted in about 5 medical institutions located in Korea, which are equal to or larger than a hospital, and patients with type 2 diabetic kidney disease (proteinuria with an ACR of 10 mg/g or higher), who are being administered or plan to be administered with antihypertensives containing fimasartan for essential hypertension, are enrolled as the subjects. Each of the subjects shall undergo follow-up for about a year (52 weeks). After explaining the purpose, method, scope of information to be collected, and procedure of this study to potential subjects, the investigator shall obtain the written consent for voluntary participation and set the day when the antihypertensive containing fimasartan is administered as the baseline. If the fimasartan-based antihypertensive treatment is already ongoing, only the patients within 6 weeks from the baseline shall be considered as the subjects. In this case, data from between the baseline and the time of the written consent shall be collected retrospectively. This study is an observational study, and the drugs which are administered during the study period and the medical procedures shall be in accordance with the clinical judgment of the investigator. It is a rule that no unnecessary intervention shall be imposed on the subjects by this study protocol.
The scope of data to be collected during this study period is as follows.
- Demographic information
- Disease information (diabetes, hypertension, renal disease, other past medical history and intercurrent diseases)
- Physical measurements (height and weight)
- Clinic blood pressure measurements
- Laboratory test results
- Antihypertensives, hypoglycemic agents, and other concomitant drugs
- Fimasartan-related adverse drug reactions and serious adverse drug reactions
- Death information (if applicable)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetic kidney disease and proteinuria (urine ACR of 10 mg/g or higher)
Key inclusion criteria (12 listed)
- Male and female adults aged 19 or older
- Those who were diagnosed with type 2 diabetes and have been being given stable doses of hypoglycemic agents for 8 weeks or longer
- Those in whom albuminuria was found to meet one of the following criteria two times before the administration of the antihypertensive treatment containing fimasartan (results (baseline values) within 4 weeks before the administration of antihypertensives must be ACR or AER results)
- Those who plan to be given antihypertensive treatment containing fimasartan for essential hypertension or are being given the treatment (in this case, those with an administration period of 6 weeks or lower can be enrolled)
- Those with records of clinical systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 85 mmHg or higher before the antihypertensive treatment containing fimasartan or at the time of the treatment. The following additional criteria shall be applied depending on age and the presence of comorbidities.
Key exclusion criteria (8 listed)
- Patients who are suspected of or confirmed with secondary hypertension
- Those diagnosed with type 1 diabetes or secondary diabetes
- Patients undergoing kidney dialysis or patients who received kidney transplants or those for whom kidney dialysis or kidney transplants are planned
- If angiotensin converting enzyme inhibitors (ACEI) or renin inhibitors are used in conjunction or are planned to be used in conjunction
- Patients with moderate to severe hepatic dysfunction (ALT and/or AST of over three times the upper limit of normal) or patients with biliary tract obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of change in albuminuria (urine ACR)
Time frame: Week 8
The descriptive statistics (number of subjects, average, standard deviation, median, minimum value, quartile, and maximum value) regarding the rate of change in albuminuria (urine ACR) at the baseline, on Week 8, and on Week 8 compared to the baseline shall be obtained
3 secondary outcomes
Quantity of change in albuminuria (urine ACR)
Time frame: Week 8
Rate of change in albuminuria (urine ACR)
Time frame: Week 26, Week 52
Rate of change in proteinuria (urine PCR)
Time frame: Week 8, Week 26, Week 52
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 12 Jul 2023.
- Individual participant dataSharing planned: No
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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.
MyungSook Hong study director
Boryung Pharmaceutical Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Kidney Disease and Proteinuria, 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 12 inclusion and 8 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 12 Jul 2023. 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.
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?
Rate of change in albuminuria (urine ACR) (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2023.