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

NCT03550859 | Unknown Phase 4

• 1 other identifier: YMC030
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 16

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR)

  baseline, week 48

Secondary Outcomes (13)

• Change from baseline to week 24 in UPCR

  baseline, week 24

• Change from baseline to week 24 and week 48 in Urine Albumin-to-Creatinine Ratio (UACR)

  baseline, week 24, week 48

• Change from baseline to week 24 and week 48 in estimated glomerular filtration rate (eGFR)

  baseline, week 24, week 48

• Change from baseline to week 48 in UPCR

  baseline, week 48

• Change from baseline to week 48 in high-sensitivity CRP (hs-CRP)

  baseline, week 48

Study Arms (2)

Duowell Tab. 40/10mg

EXPERIMENTAL

Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks

Drug: Telmisartan/Rosuvastatin 40/10mg

Micardis Tab. 40mg

ACTIVE COMPARATOR

Telmisartan 40mg qd for 48 weeks

Drug: Telmisartan 40mg

Interventions

Telmisartan/Rosuvastatin 40/10mg DRUG

Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks

Duowell Tab. 40/10mg

Telmisartan 40mg DRUG

Telmisartan 40mg qd for 48 weeks

Micardis Tab. 40mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (16)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

RECRUITING

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Korea University Ansan Hospital

Ansan, Gyeonggido, South Korea

RECRUITING

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

RECRUITING

Dong-A University Hospital

Busan, South Korea

NOT YET RECRUITING

Kyungpook National University Hospital

Daegu, South Korea

RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

NOT YET RECRUITING

Inje University Ilsan Paik Hospital

Goyang, South Korea

RECRUITING

The Catholic University of Korea Incheon St.Mary's Hospital

Incheon, South Korea

RECRUITING

Presbyterian Medical Center

Jeonju, South Korea

NOT YET RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

NOT YET RECRUITING

Hallym University Kangnam Sacred Heart Hospital

Seoul, South Korea

RECRUITING

korea Universitiy Anam Hospital

Seoul, South Korea

NOT YET RECRUITING

KyungHee Universitiy Hospital at Gandong

Seoul, South Korea

RECRUITING

SMG-SNU Boramae Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria

Interventions

Telmisartan; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 8, 2018
• Study Start: June 5, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

KR (16)