Clinical trial NCT06322056: Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease
Official title: Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Hypertension
Dyslipidemias
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 642
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The EXploring approaChEs with Lower targets of blood preSsure and lIpid for impOving Renal outcome in advanced Chronic Kidney Disease (EXCELSIOR-CKD) strived to enroll about 642 participants aged ≥19 years with eGFR 15-45 mL/min/1.73 m2, systolic blood pressure (SBP) ≥130 mmHg, and low-density lipoprotein cholesterol (LDL-C) ≥100 mg/dL.

The EXCELSIOR-CKD study is a 2X2 factorial design with factors consisting of: intensive versus standard SBP control (120 vs 140 mmHg), and intensive versus standard LDL-C control (70 vs 100 mg/dL).

The primary hypothesis was that kidney disease progression event rates would be lower in the intensive arms. Participants would be recruited at 13 clinics over approximately a 2-year period, and are planned to be followed for 3 years.

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%

Primary outcomes:
measure: Renal composite outcome
timeFrame: up to 3 years
Secondary outcomes:
measure: Individual components of renal composite outcome
timeFrame: up to 3 years
measure: eGFR slopes
timeFrame: up to 3 years
measure: Cardiovascular composite outcome
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: