Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT06322056

Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease

Led by Yonsei University · Updated on 2024-12-16

642

Participants Needed

1

Research Sites

276 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to prevent kidney disease progression in adults with advanced chronic kidney disease (estimated glomerular filtration rate \[eGFR\] between 15-45 mL/min/1.73 m2) using intensive blood pressure control and intensive lipid management with 2X2 factorial design.

CONDITIONS

Official Title

Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 19 years old
  • Chronic kidney disease (CKD) confirmed for at least 3 months with eGFR between 15 and less than 45 mL/min/1.73 m2
  • Systolic blood pressure (SBP) between 130-180 mmHg on 0 or 1 medication, or 130-170 mmHg on up to 2 medications, or 130-160 mmHg on more than 3 medications
  • Low-density lipoprotein cholesterol (LDL-C) of 100 mg/dL or higher
Not Eligible

You will not qualify if you...

  • Resistant or poorly controlled hypertension (unable to reach SBP less than 140 mmHg despite 4 or more blood pressure medications including diuretics)
  • Known secondary causes of hypertension
  • History of renal denervation procedure
  • Glomerulonephritis requiring immunosuppressive treatment
  • Autosomal dominant polycystic kidney disease treated with tolvaptan
  • eGFR less than 15 mL/min/1.73 m2 or currently on kidney replacement therapy
  • Familial hypercholesterolemia
  • Cardiovascular event or procedure within last 3 months or planned within 3 months
  • Symptomatic heart failure within 6 months with low heart function
  • Medical condition limiting survival to less than 3 years
  • Cancer diagnosis within last 5 years or receiving chemotherapy or radiotherapy
  • Any organ transplant
  • Advanced liver disease or abnormal liver function tests
  • Active inflammatory muscle disease or high creatine kinase levels
  • History of adverse reaction to statins or ezetimibe
  • Use of specific medications including nicotinic acid, certain antibiotics, antifungals, protease inhibitors, nefazodone, or immunosuppressive agents
  • Pregnancy or trying to become pregnant
  • Type I diabetes
  • Type II diabetes with poorly controlled blood sugar (HbA1c 10.0% or higher)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Severance Hospital

Seoul, South Korea, 03722

Actively Recruiting

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Research Team

S

Seung Hyeok Han

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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