HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria

December 11, 2020 updated by: Yuhan Corporation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
374

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Not yet recruiting
        • Dong-A University Hospital
      • Daegu, Korea, Republic of
        • Recruiting
        • Kyungpook National University Hospital
        • Contact:
        • Principal Investigator:
          • SunHee Park, MD PhD
      • Daejeon, Korea, Republic of
        • Not yet recruiting
        • Chungnam National University Hospital
        • Contact:
        • Principal Investigator:
          • DaeEun Choi, MD PhD
      • Goyang, Korea, Republic of
        • Recruiting
        • Inje University Ilsan Paik Hospital
        • Contact:
        • Principal Investigator:
          • Sang-Youb Han, MD PhD
      • Incheon, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea Incheon St.Mary's Hospital
        • Contact:
        • Principal Investigator:
          • SeokJoon Shin, MD PhD
      • Jeonju, Korea, Republic of
        • Not yet recruiting
        • Presbyterian Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • SMG-SNU Boramae Medical Center
        • Contact:
        • Principal Investigator:
          • Chun Soo Lim, MD PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Hallym University Kangnam Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Young-Ki Lee, MD PhD
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • korea Universitiy Anam Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • KyungHee Universitiy Hospital at Gandong
        • Contact:
        • Principal Investigator:
          • Ju Young MOON, MD PhD
    • Gangwon-do
      • Wŏnju, Gangwon-do, Korea, Republic of
        • Recruiting
        • Wonju Severance Christian Hospital
        • Contact:
        • Principal Investigator:
          • ByungGeun Han, MD PhD
    • Gyeonggi-do
      • Anyang, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Hallym University Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Seong-Gyun Kim, MD PhD
      • Seongnam, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Ki-Young Na, MD PhD
    • Gyeonggido
      • Ansan, Gyeonggido, Korea, Republic of
        • Recruiting
        • Korea University Ansan Hospital
        • Contact:
        • Principal Investigator:
          • DaeRyong Cha, MD PhD
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of
        • Recruiting
        • Chonbuk National University Hospital
        • Contact:
        • Principal Investigator:
          • Wok Kim, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged ≥ 19 years
  2. Chronic Kidney Disease (CKD) with CKD stage G2 or G3 and 300 mg/g ≤ urine PCR ≤ 3000 mg/g
  3. Diagnosed with hypertension
  4. Written informed consent
  5. Patients who have not administered statin (including rosuvastatin) and hyperlipidemia treatment for at least 4 weeks prior to randomization

Exclusion Criteria:

  1. Type I diabetes
  2. Uncontrolled diabetic patients with HbA1c > 10% at screening
  3. 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
  4. Calculated LDL-C ≥ 160 mg/dL at randomization
  5. Patients who have taken RAS blockers (ACE inhibitor, ARB, and Aldosterone antagonist) for 4 weeks prior to randomization
  6. Heart failure patients with NYHA class IV
  7. Patients with acute and chronic liver disease, acute inflammation, hematologic abnormalities and cancer within the last 6 months
  8. 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)
  9. Patients taking immunosuppressive drugs
  10. Patients undergoing eGFR <30 mL/min/1.73 m2 (CKD-EPI formula) or renal replacement therapy (dialysis or renal transplant) at screening
  11. Patients with a change in eGFR (CKD-EPI formula) value showing a difference of more than 30% in the last 6 months at screening
  12. Creatine kinase (CK) level ≥ 3x ULN (upper limit of normal range)
  13. Patients who are pregnant or planning to become pregnant
  14. Contraindications stated in the SPC of telmisartan or rosuvastatin
  15. Those participating in other clinical trials for investigational products at screening
  16. Patients deemed to be ineligible to participate in the trial by investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Duowell Tab. 40/10mg
Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks
Drug: Telmisartan/Rosuvastatin 40/10mg
Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks
ACTIVE_COMPARATOR: Micardis Tab. 40mg
Telmisartan 40mg qd for 48 weeks
Drug: Telmisartan 40mg
Telmisartan 40mg qd for 48 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR)
Time Frame: baseline, week 48
baseline, week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline to week 24 in UPCR
Time Frame: baseline, week 24
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
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
baseline, week 24, week 48
Change from baseline to week 48 in UPCR
Time Frame: baseline, week 48
baseline, week 48
Change from baseline to week 48 in high-sensitivity CRP (hs-CRP)
Time Frame: baseline, week 48
baseline, week 48
Change from baseline to week 48 in HOMA-insulin resistance (HOMA-IR)
Time Frame: baseline, week 48
baseline, week 48
Change from baseline to week 48 in 24hr urine protein
Time Frame: baseline, week 48
baseline, week 48
Proportion of subjects whose UPCR decreased by more than 30% at 48 weeks
Time Frame: baseline, week 48
baseline, week 48
Change from baseline to week 48 in MCP-1 (monocyte chemoattractant protein 1)
Time Frame: baseline, week 48
baseline, week 48
Change from baseline to week 48 in urinary 8-isoprostane
Time Frame: baseline, week 48
baseline, week 48
Change from baseline to week 48 in urine nephrin
Time Frame: baseline, week 48
baseline, week 48
Change from baseline to week 48 in type IV collagen
Time Frame: baseline, week 48
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
baseline, week 12, week 24, week 36, week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuhan Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YMC030

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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