Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe CKD

• Status: Not yet recruiting
• Trial end date: 2024-03-15
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 3, randomized, Double-blind, placebo-controlled, 2-arm, parallel-group, multicenter study with randomized withdrawal will evaluate the efficacy, safety, and durability of KBP-5074 in adult participants who have stage 3b/4 chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] ≥15 to ≤44 mL/min/1.73 m^2) and uncontrolled hypertension (systolic blood pressure (SBP) ≥140 and <180 mm Hg and taking 2 or more antihypertensive medications.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KBP Biosciences

Criteria

Inclusion Criteria:

• 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 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 ≥30 and ≤44 mL/min/1.73 m^2) or Stage 4 (eGFR ≥15 and <30 mL/min/1.73 m^2) CKD

Exclusion Criteria:

• 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

• 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 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 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)

• Participant has taken a strong cytochrome P450 (CYP) CYP3A4 inducer or strong CYP3A4 inhibitor during the 7 days before the Randomization Visit (Visit 3)