NCT04968184

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

A Phase 3 Randomized Double-Blind Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of KBP-5074 Mineralocorticoid Receptor Antagonist in Subjects With Uncontrolled Hypertension and Moderate or Severe (Stage 3b/4) CKD

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 652 (actual)
• Sponsor: KBP Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \[eGFR\] calculated using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula \[eGFR {EPI}\] ≥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.

Detailed description

Participants in this study will be recruited, screened, and enrolled at approximately 140 study sites globally. The study will consist of the following periods: 1. Pretreatment Phase: This will include prescreening assessment and screening period of up to 4 weeks and 2-week Open-label placebo Run-In period. 2. A 24-week Double-blind Treatment Period (Randomization to Week 24) will include: An initial 12-week (Randomization to Week 12) and second 12-week (Week 12 to Week 24) treatment period and a second 12-week treatment period (Week 12 to Week 24), during both the periods study drug will be titrated. 3. A 24-week Open-label Treatment Period (Week 24 to Week 48) during which eligible participants will receive Open-label KBP-5074. 4. A 4-week Randomized Double-blind Withdrawal Period (Week 48 to Week 52) during which eligible participants will be randomized to continue their current KBP-5074 dose at the end of Open-label treatment or receive matching placebo for 4 weeks. 5. A 4-week post-treatment Follow-Up Period (Week 52 to Week 56). During, 24-week Double-blind Treatment Period, 24-week Open-label Treatment Period, and at 4-week Randomized Double-blind Withdrawal Period, the background antihypertensive medications change may or may not be allowed. At Double-blind Treatment Period, eligible participants will be randomly assigned in a 1:1 ratio to KBP-5074 0.25 mg or matching placebo once daily (QD). At the Randomized Double-blind Withdrawal Period, participants who meet the randomized withdrawal criteria will be randomly assigned in a 1:1 ratio to continue their current KBP-5074 dose at the end of the Open-label Treatment Period or matching placebo QD.

Conditions

• Chronic Kidney Diseases

Interventions

Type	Name	Description
DRUG	Placebo	Participants will orally receive placebo matching to KBP-5074 tablets QD.
DRUG	KBP-5074	Participants will orally receive KBP-5074 tablets, from 0.25 mg to a maximum dose of 0.5-mg QD.

Timeline

• Start date: 2021-11-05
• Primary completion: 2024-01-30
• Completion: 2024-07-10
• First posted: 2021-07-20
• Last updated: 2025-09-03

Locations

215 sites across 22 countries: United States, Australia, Bosnia and Herzegovina, Bulgaria, Canada, China, Croatia, Czechia, Georgia, Germany, Hong Kong, Hungary, Israel, Latvia, Lithuania, Malaysia, Poland, Serbia, South Africa, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study