Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease
Recruiting · NCT06322056 · Interventional (participants receive a specific treatment) · Lead sponsor: Yonsei University
View the official record on ClinicalTrials.gov →Interventions studied
Intensive control of SBP and intensive control of LDL-CIntensive control of SBP and standard control of LDL-CStandard control of SBP and intensive control of LDL-CStandard control of SBP and standard control of LDL-C
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.
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Fulfillment of all of followings
- At least 19 years old
- Evidence of CKD defined at least 3 months before and at the time of screening visit with CKD-EPI eGFR ≥15 to \<45 mL/min/1.73 m2
- SBP of
- 130-180 mmHg on 0 or 1 medication
- 130-170 mmHg on upto 2 medications
- 130-160 mmHg on more than 3 medications
- LDL-C ≥100 mg/dL
Exclusion criteria
- Any of followings
- Resistant hypertension or poorly controlled hypertension
- Failure to achieve SBP of \<140 mmHg despite using 4 or more antihypertensive medications including diuretics
- Known secondary cause of hypertension
- History of renal devervation procedure
- Glomerulonephritis requiring immunosuppresive agents
- Autosomal dominant polycystic kidney disease receiving tolvaptan
- CKD-EPI \< 15 mL/min/1.73 m2 or receiving kidney replacement therapy
- Familial hypercholesterolemia
- Cardiovascular event or precedure (as defined as myocardial infarction, unstable angina, coronary revascularization, or stroke) within last 3 months or planning to cardiovascular procedure upcoming 3 months at the time of screening visit
- Symptomatic heart failure within 6 months of left ventricular ejection fraction \<45%
- A medical condition likely to limit survival to less thant 3 years
- Diagnosis of malignancy within the last 5 years or undergoing chemotherepy or radiotherapy
- Any organ transplant
- Advanced cirrhosis (Child-Pugh class B or C) or abnormal liver function test (alanine transaminase or aspartate transaminase ≥1.5 X upper normal limit)
- Evidence of active inflammatory muscle disease (polymyositis or dermatomyositis) or creatine kinase elevation (≥3 X upper normal limit)
- History of adverse reaction to HMG-CoA reductase inhibitors or ezetimibe
- Using any drugs as followings:
- Nicotinic acid
- Macrolide antibiotics
- Systemic imidazole or triazole antifungal agent
- Protease inhibitor
- Nefazodone
- Immunosuppressive agents (glucocorticoid \[equivalent to prednisone 10 mg/day over 4 weeks\], cyclosporin, mycofenolate, azathioprine, methotrexate, cyclophosphamide, or rituximab)
- Pregnancy or trying to become pregnant
- Diabetes mellitus, type I
- Diabetes mellitus, type II with HbA1c ≥10.0%
Where it is running
2 locations listed.
- Severance Hospital - Seoul, South Korea
- Severance Hospital - Seoul, South Korea