Chronic Kidney DiseasePhase 4NCT03550859
HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria
A Phase 4 study testing Telmisartan/Rosuvastatin 40/10mg and Telmisartan 40mg in people with Chronic Kidney Disease and Proteinuria, run by Yuhan Corporation at 16 sites in South Korea.
Trial summary
This study is to evaluate the renal function of HMG-CoA reductase add-on in chronic kidney disease patients with proteinuria. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Kidney Disease, Proteinuria
- What is being tested?
- Telmisartan/Rosuvastatin 40/10mg and Telmisartan 40mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 16 sitesSouth Korea
- Study dates
- 5 Jun 2018to Dec 2021
- Phase
- Phase 4
- 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
- Aged ≥ 19 years
- Chronic Kidney Disease (CKD) with CKD stage G2 or G3 and 300 mg/g ≤ urine PCR ≤ 3000 mg/g
- Diagnosed with hypertension
- Written informed consent
- Patients who have not administered statin (including rosuvastatin) and hyperlipidemia treatment for at least 4 weeks prior to randomization
Who cannot join
- Type I diabetes
- Uncontrolled diabetic patients with HbA1c > 10% at screening
- Hypertensive patients whose mean blood pressure was not controlled at 160/90 mmHg or more in triplicate despite the use of antihypertensive agents at the time of randomization
- Calculated LDL-C ≥ 160 mg/dL at randomization
- Patients who have taken RAS blockers (ACE inhibitor, ARB, and Aldosterone antagonist) for 4 weeks prior to randomization
- Heart failure patients with NYHA class IV
Show all 16Show fewer
- Patients with acute and chronic liver disease, acute inflammation, hematologic abnormalities and cancer within the last 6 months
- Patients with a history of cerebral blood cardiovascular complications (cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass, and percutaneous coronary intervention)
- Patients taking immunosuppressive drugs
- Patients undergoing eGFR <30 mL/min/1.73 m2 (CKD-EPI formula) or renal replacement therapy (dialysis or renal transplant) at screening
- Patients with a change in eGFR (CKD-EPI formula) value showing a difference of more than 30% in the last 6 months at screening
- Creatine kinase (CK) level ≥ 3x ULN (upper limit of normal range)
- Patients who are pregnant or planning to become pregnant
- Contraindications stated in the SPC of telmisartan or rosuvastatin
- Those participating in other clinical trials for investigational products at screening
- Patients deemed to be ineligible to participate in the trial by investigator
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
South Korea16 sites, 16 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan, Gyeonggido
SangMin Lee, +82-31-412-6764, 3blue9@naver.com
DaeRyong Cha, MD PhD
- Recruiting
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do
SangMi Oh, +82-31-380-1770, jinmi0320@gmail.com
Seong-Gyun Kim, MD PhD
- Not yet recruiting
Dong-A University Hospital
Busan
- Recruiting
Kyungpook National University Hospital
Daegu
HwaYoung Lee, +82-53-200-6947, dlghkdud1225@naver.com
SunHee Park, MD PhD
- Not yet recruiting
Chungnam National University Hospital
Daejeon
SeongJin Hong, +82-42-280-6948, hsj0674@cnuh.co.kr
DaeEun Choi, MD PhD
- Recruiting
Inje University Ilsan Paik Hospital
Goyang
HeeJaa Lee, +82-31-910-7776, heejaalee@naver.com
Sang-Youb Han, MD PhD
- Recruiting
The Catholic University of Korea Incheon St.Mary's Hospital
Incheon
SoonGuem Lee, +82-32-280-5188, endo-zzang@daum.net
SeokJoon Shin, MD PhD
- Recruiting
Chonbuk National University Hospital
Jeonju, Jeollabuk-do
YunJeong Chae, +82-63-250-1284, cyj70105@hanmail.net
Wok Kim, MD PhD
- Not yet recruiting
Presbyterian Medical Center
Jeonju
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
HyunJin Cho, +82-31-787-7030, 10871@snubh.org
Ki-Young Na, MD PhD
- Not yet recruiting
Gangnam Severance Hospital
Seoul
- Recruiting
Hallym University Kangnam Sacred Heart Hospital
Seoul
MiRan Choi, +82-2-829-5215, hellocherry@hanmail.net
Young-Ki Lee, MD PhD
- Not yet recruiting
korea Universitiy Anam Hospital
Seoul
- Recruiting
KyungHee Universitiy Hospital at Gandong
Seoul
JiHyun Kim, +82-2-440-7065, cell41@naver.com
Ju Young MOON, MD PhD
- Recruiting
SMG-SNU Boramae Medical Center
Seoul
JiYoung Kim, +82-2-870-3875, smile0212@daum.net
Chun Soo Lim, MD PhD
- Recruiting
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do
InJyung Kim, +82-33-749-0937, noblessik@hanmail.net
ByungGeun Han, MD PhD
About this study
Official title: Randomized, Open, Multicenter Study to Evaluate the Renal Function of HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria
This study is to evaluate the renal function of HMG-CoA reductase add-on in chronic kidney disease patients with proteinuria.
- Conditions
- Chronic Kidney Disease, Proteinuria
- Being tested
- Telmisartan/Rosuvastatin 40/10mg, Telmisartan 40mg
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan/Rosuvastatin 40/10mgDrug
Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks
Telmisartan 40mgDrug
Telmisartan 40mg qd for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Duowell Tab. 40/10mg | Experimental | Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks Receives: Drug: Telmisartan/Rosuvastatin 40/10mg |
| Micardis Tab. 40mg | Active comparator | Telmisartan 40mg qd for 48 weeks Receives: Drug: Telmisartan 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR)
Measured: baseline, week 48
Secondary outcomes (13)
Change from baseline to week 24 in UPCR
Measured: baseline, week 24
Change from baseline to week 24 and week 48 in Urine Albumin-to-Creatinine Ratio (UACR)
Measured: baseline, week 24, week 48
Change from baseline to week 24 and week 48 in estimated glomerular filtration rate (eGFR)
Measured: baseline, week 24, week 48
Change from baseline to week 48 in UPCR
Measured: baseline, week 48
Change from baseline to week 48 in high-sensitivity CRP (hs-CRP)
Measured: baseline, week 48
Change from baseline to week 48 in HOMA-insulin resistance (HOMA-IR)
Measured: baseline, week 48
Change from baseline to week 48 in 24hr urine protein
Measured: baseline, week 48
Proportion of subjects whose UPCR decreased by more than 30% at 48 weeks
Measured: baseline, week 48
Change from baseline to week 48 in MCP-1 (monocyte chemoattractant protein 1)
Measured: baseline, week 48
Change from baseline to week 48 in urinary 8-isoprostane
Measured: baseline, week 48
Change from baseline to week 48 in urine nephrin
Measured: baseline, week 48
Change from baseline to week 48 in type IV collagen
Measured: baseline, week 48
Proportion of subjects who received renal replacement therapy (dialysis or renal transplant) at 12, 24, 36, or 48 weeks
Measured: baseline, week 12, week 24, week 36, week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start5 Jun 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550859
- Sponsor's protocol ID
- YMC030
- Status last verified
- Dec 2020
- First submitted
- 9 May 2018
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open, Multicenter Study to Evaluate the Renal Function of HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria
- ClinicalTrials.gov ID
- NCT03550859
- Acronym / sponsor ID
- YMC030
- Conditions
- Chronic Kidney Disease, Proteinuria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Jun 2018 (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 is to evaluate the renal function of HMG-CoA reductase add-on in chronic kidney disease patients with proteinuria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duowell Tab. 40/10mg | Experimental | Drug: Telmisartan/Rosuvastatin 40/10mgTelmisartan/Rosuvastatin 40/10mg qd for 48 weeks |
| Micardis Tab. 40mg | Active comparator | Drug: Telmisartan 40mgTelmisartan 40mg qd for 48 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥ 19 years
- Chronic Kidney Disease (CKD) with CKD stage G2 or G3 and 300 mg/g ≤ urine PCR ≤ 3000 mg/g
- Diagnosed with hypertension
- Written informed consent
- Patients who have not administered statin (including rosuvastatin) and hyperlipidemia treatment for at least 4 weeks prior to randomization
Key exclusion criteria (16 listed)
- Type I diabetes
- Uncontrolled diabetic patients with HbA1c > 10% at screening
- Hypertensive patients whose mean blood pressure was not controlled at 160/90 mmHg or more in triplicate despite the use of antihypertensive agents at the time of randomization
- Calculated LDL-C ≥ 160 mg/dL at randomization
- Patients who have taken RAS blockers (ACE inhibitor, ARB, and Aldosterone antagonist) for 4 weeks prior to randomization
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 |
|---|---|---|
| Telmisartan/Rosuvastatin 40/10mgTelmisartan/Rosuvastatin 40/10mg qd for 48 weeks | Drug | Duowell Tab. 40/10mg |
| Telmisartan 40mgTelmisartan 40mg qd for 48 weeks | Drug | Micardis Tab. 40mg |
Primary outcome
Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR)
Time frame: baseline, week 48
13 secondary outcomes
Change from baseline to week 24 in UPCR
Time frame: baseline, week 24
Change from baseline to week 24 and week 48 in Urine Albumin-to-Creatinine Ratio (UACR)
Time frame: baseline, week 24, week 48
Change from baseline to week 24 and week 48 in estimated glomerular filtration rate (eGFR)
Time frame: baseline, week 24, week 48
Change from baseline to week 48 in UPCR
Time frame: baseline, week 48
Change from baseline to week 48 in high-sensitivity CRP (hs-CRP)
Time frame: baseline, week 48
Change from baseline to week 48 in HOMA-insulin resistance (HOMA-IR)
Time frame: baseline, week 48
Change from baseline to week 48 in 24hr urine protein
Time frame: baseline, week 48
Proportion of subjects whose UPCR decreased by more than 30% at 48 weeks
Time frame: baseline, week 48
Change from baseline to week 48 in MCP-1 (monocyte chemoattractant protein 1)
Time frame: baseline, week 48
Change from baseline to week 48 in urinary 8-isoprostane
Time frame: baseline, week 48
Change from baseline to week 48 in urine nephrin
Time frame: baseline, week 48
Change from baseline to week 48 in type IV collagen
Time frame: baseline, week 48
Proportion of subjects who received renal replacement therapy (dialysis or renal transplant) at 12, 24, 36, or 48 weeks
Time frame: baseline, week 12, week 24, week 36, week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
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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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telmisartan/Rosuvastatin 40/10mg and Telmisartan 40mg in people with Chronic Kidney Disease and Proteinuria, run by Yuhan Corporation at 16 sites 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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR) (time frame: baseline, week 48). 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 14 Dec 2020.