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NCT04968184 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by KBP Biosciences.

Terminated
Registry status
Phase 3
Development phase
652
Enrollment target

NCT04968184: Clinical Trial Phase 3 study, sponsored by KBP Biosciences.

NCT04968184 is a Phase 3 study that was terminated before completion, run by KBP Biosciences. The registered enrollment target is 652 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04968184, a Phase 3 study, was terminated before completion, sponsored by KBP Biosciences.

TERMINATED
Registry status
Phase 3
Development phase
652 participants
Enrollment target

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.

Primary Outcome

Efficacy of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP for KBP-5074 dose regimen compared to placebo, will be evaluated.

Interventions

  • DRUG Placebo
  • DRUG KBP-5074

Trial Details

FieldValue
Enrollment Target 652 participants
Start Date 2021-11-05
Est. Completion 2024-07-10
Phase Phase 3
KBP Biosciences

12 total trials

Why NCT04968184 stopped before completion

NCT04968184 is an interventional study that assigns participants to a tested intervention. The registered 652 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04968184 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04968184 about?

NCT04968184 is a clinical study titled "Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe Chronic Kidney Disease (CKD)". 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 ...

What is the current status of trial NCT04968184?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 652 participants. The study started on 2021-11-05. Estimated completion is 2024-07-10.

What interventions are being tested in trial NCT04968184?

The interventions under investigation include: Placebo (DRUG), KBP-5074 (DRUG).

Who is sponsoring clinical trial NCT04968184?

This trial is sponsored by KBP Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04968184's enrollment target sits among peer trials

652 571st of 2000 higher than 1,429 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04968184, the US trial registry maintained by the National Library of Medicine. NCT04968184 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.