Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe Chronic Kidney Disease (CKD)

Korábbi kezelés

• Participant has been hospitalized for hyperkalemia within the 3 months before the Randomization Visit (Visit 3)
• Participant was not compliant with taking placebo during the Run-in Period or participant was not compliant with background antihypertensive medications during the Run-in Period as assessed at the Randomization Visit (Visit 3)
• Participant has taken a strong cytochrome P450 (CYP) CYP3A4 inducer or strong CYP3A4 inhibitor during the 7 days before the Randomization Visit (Visit 3)
• Participant has taken a prohibited traditional Chinese medication during the 28 days prior to Screening Visit (Visit 1).
• Participant was administered any other investigational product within 4 weeks or 5 half-lives (whichever is longer) prior to the Screening Visit (Visit 1).

Laborértékek

• Participant has a serum potassium level >4.8 mmol/L during the Screening or Run-In Periods
• Participant has had a serum potassium level >5.6 mmol/L within 2 weeks before the Screening Visit (Visit 1)
• Participant has taken an mineralocorticoid receptor antagonist (MRA), a potassium-sparing diuretic, or chronic potassium supplements during the 4 weeks before the Screening Visit (Visit 1)
• Participant has taken potassium binders for the treatment of hyperkalemia during the 3 months before the Screening Visit (Visit 1)

Egyéb

• Participant has a resting seated trough cuff SBP ≥180 mm Hg at the Screening Visit (Visit 1) or at the start (Visit 2) or end (Visit 3) of the Run-In Period

• Body mass index (BMI) must be ≥19 to <45 kg/m\^2 at the Screening Visit
• Participant must have uncontrolled hypertension defined as meeting both of the following criteria:
  • The participant has a resting seated trough cuff SBP ≥140 mm Hg at the Screening Visit (Visit 1), and at the start (Visit 2) and end (Visit 3) of the Run-In Period
  • The participant is taking 2 or more antihypertensive medications that have been titrated upward as tolerated to hypertension target doses per local SoC and have been stable (i.e., without any dose adjustments) from 4 weeks before the Screening Visit (Visit 1) through the end of the Run-In Period (Visit 3)
• The participant must have Stage 3b (eGFR [EPI] ≥30 and ≤44 mL/min/1.73 m\^2) or Stage 4 (eGFR [EPI] ≥15 and <30 mL/min/1.73 m\^2) CKD.