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

NCT04968184 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 652

Last updated 2025-09-03

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Diseases

Interventions

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.

Sponsors & Collaborators

  • KBP Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-05
Primary Completion
2024-01-30
Completion
2024-07-10
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04968184 on ClinicalTrials.gov