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

Launched by YONSEI UNIVERSITY · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking into ways to prevent the progression of kidney disease in adults who have advanced chronic kidney disease (CKD). Specifically, the study aims to see if controlling blood pressure and cholesterol levels more strictly can help improve kidney health. Participants in this trial will be adults aged 19 and older who have a specific range of kidney function (measured by a test called eGFR) and meet certain blood pressure and cholesterol criteria.

If you or a loved one is interested in participating, you should be aware that some conditions may exclude you, such as having poorly controlled high blood pressure or certain heart problems. During the study, participants can expect close monitoring of their blood pressure and cholesterol while receiving standard care for their kidney health. This trial is currently recruiting, and it may offer valuable insights into managing kidney disease more effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Fulfillment of all of followings
• • 1. At least 19 years old
• • 2. 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
• • 3. 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
• • 4. LDL-C ≥100 mg/dL
• Exclusion Criteria:
• • Any of followings
• • 1. Resistant hypertension or poorly controlled hypertension
• • Failure to achieve SBP of \<140 mmHg despite using 4 or more antihypertensive medications including diuretics
• • 2. Known secondary cause of hypertension
• • 3. History of renal devervation procedure
• • 4. Glomerulonephritis requiring immunosuppresive agents
• • 5. Autosomal dominant polycystic kidney disease receiving tolvaptan
• • 6. CKD-EPI \< 15 mL/min/1.73 m2 or receiving kidney replacement therapy
• • 7. Familial hypercholesterolemia
• • 8. 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
• • 9. Symptomatic heart failure within 6 months of left ventricular ejection fraction \<45%
• • 10. A medical condition likely to limit survival to less thant 3 years
• • 11. Diagnosis of malignancy within the last 5 years or undergoing chemotherepy or radiotherapy
• • 12. Any organ transplant
• • 13. Advanced cirrhosis (Child-Pugh class B or C) or abnormal liver function test (alanine transaminase or aspartate transaminase ≥1.5 X upper normal limit)
• • 14. Evidence of active inflammatory muscle disease (polymyositis or dermatomyositis) or creatine kinase elevation (≥3 X upper normal limit)
• • 15. History of adverse reaction to HMG-CoA reductase inhibitors or ezetimibe
• 16. 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)
• • 17. Pregnancy or trying to become pregnant
• • 18. Diabetes mellitus, type I
• • 19. Diabetes mellitus, type II with HbA1c ≥10.0%