Lowering blood pressure and cholesterol to improve kidney health in advanced chronic kidney disease

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

This study is testing if better control of blood pressure and cholesterol can help adults with advanced kidney disease feel better and slow down the progression of their condition.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 642 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Yonsei University (Academic / other)
• Drugs / interventions: rituximab, methotrexate, cyclophosphamide, prednisone
• Locations: 1 site (Seoul)
• Trial ID: NCT06322056 on ClinicalTrials.gov

What this trial studies

This study aims to prevent the progression of kidney disease in adults with advanced chronic kidney disease by implementing intensive control of blood pressure and lipid levels. It utilizes a 2X2 factorial design to compare the effects of intensive versus standard blood pressure control and intensive versus standard lipid management. Approximately 642 participants aged 19 and older with specific criteria will be enrolled and followed for three years to assess kidney disease progression. The study is conducted across 13 clinics over a two-year recruitment period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older with advanced chronic kidney disease and specific blood pressure and cholesterol levels.

Not a fit: Patients with resistant hypertension, poorly controlled hypertension, or those with certain kidney diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly slow the progression of kidney disease in patients with advanced chronic kidney disease.

How similar studies have performed: Other studies have shown promising results with intensive management of blood pressure and lipids in chronic kidney disease, indicating potential for success in this approach.

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%

Where this trial is running

Seoul

• Severance Hospital — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Seung Hyeok Han

Conditions Chronic Kidney Diseases; Hypertension; Dyslipidemias