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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Chronic Kidney Diseases

In brief

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.

Key facts

Study ID

NCT04968184

Run by

KBP Biosciences

People needed

652

Starts

2021-11-05

Expected to finish

2024-07-10

Last updated by the study team

2025-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 per local SoC and have been stable (i.e., without any dose adjustments) 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 [EPI] ≥30 and ≤44 mL/min/1.73 m\^2) or Stage 4 (eGFR [EPI] ≥15 and <30 mL/min/1.73 m\^2) CKD.

You may not qualify if…

• 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)
• Participant has taken a prohibited traditional Chinese medication during the 28 days prior to Screening Visit (Visit 1).
• Participant was administered any other investigational product within 4 weeks or 5 half-lives (whichever is longer) prior to the Screening Visit (Visit 1).

Where it is running

• Apogee Clinical Research, LLC — Huntsville, Alabama, United States
• Aventiv Research, Inc — Mesa, Arizona, United States
• National Heart Institute — Beverly Hills, California, United States
• Amicis Research Center (Valencia) — Granada Hills, California, United States
• Amicis Research Center — Granada Hills, California, United States
• Amicis Research Center — Lancaster, California, United States
• Renal Consultants Medical Group - Granada Hills — Northridge, California, United States
• United Clinical Research and Innovations — South Gate, California, United States
• Solano Kidney Care — Vacaville, California, United States
• Desert Cities Dialysis - Amethyst — Victorville, California, United States
• Kidney and Hypertension Center — Victorville, California, United States
• Davita Clinical Research-Hartford — Bloomfield, Connecticut, United States
• Synergy Healthcare — Bradenton, Florida, United States
• Homestead Associates in Research, Inc — Miami, Florida, United States
• Total Research Group — Miami, Florida, United States
• LCC Medical Research — Miami, Florida, United States
• Oceane 7 Medical&Research Center, Inc. — Miami, Florida, United States
• Allied Biomedical Research Institute — Miami, Florida, United States
• South Florida Research Phase I-Iv, Inc. — Miami, Florida, United States
• San Marcus Research Clinic, Inc. — Miami Lakes, Florida, United States
• Inpatient Research Clinic, LLC — Miami Lakes, Florida, United States
• New Generation Of Medical Research — Naples, Florida, United States
• Sarkis Clinical — Ocala, Florida, United States
• Omega Research Orlando, LLC — Orlando, Florida, United States
• G & L Research, LLC — Foley, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.