drugset / Trial / NCT04968184

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

NCT04968184 ↗

Phase 3 Terminated 652 enrolled KBP Biosciences
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-11-05
Primary completion
2024-01-30
Completion
2024-07-10

Outcome

Outcome not reported

Stopped: “Interim futility analysis showed primary endpoint not achieved”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ocedurenone Small molecule 0.5 mg Oral