A Study to Assess the Efficacy and Safety of KBP-5074, in Subjects with Uncontrolled Hypertension Who Have Moderate or Severe (Stage 3b/4) Chronic Kidney Disease

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of KBP-5074, a Mineralocorticoid Receptor Antagonist, in Subjects with Uncontrolled Hypertension Who Have Moderate or Severe (Stage 3b/4) Chronic Kidney Disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003636-88-BG

Enrollment

652

Registered

2022-06-16

Start date

2022-09-30

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncontrolled hypertension in patients who have Stage 3b/4 chronic kidney disease MedDRA version: 21.1 Level: LLT Classification code 10066860 Term: Uncontrolled hypertension System Organ Class: 10047065 - Vascular disorders MedDRA version: 23.1 Level: LLT Classification code 10076410 Term: Chronic kidney disease stage 3 System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 23.1 Level: LLT Classification code 10076411 Term: Chronic kidney disease stage 4 System Organ Class

Interventions

Product Name: KBP-5074 Product Code: KBP-5074 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Not available CAS Number: 1359969-24-6 Current Sponsor code: KBP-5074 Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subject must be =18 years of age at the Screening Visit (Visit 1). • Body mass index (BMI) must be =19 to =65 years) yes F.1.3.1 Number of subjects for this age range 451

Exclusion criteria

Exclusion criteria: Subject has a serum potassium level >4.8 mmol/L according to central laboratory results during the Screening or Run-In Periods. • Subject has had a serum potassium level >5.6 mmol/L within 2 weeks before the Screening Visit (Visit 1). • Subject has been hospitalizated for hyperkalemia within the 3 months before the Randomization Visit (Visit 3). • Subject was not compliant with taking placebo during the Run-in Period (defined as taking 120% of planned placebo doses) or the Investigator determines that the subject was not compliant with background antihypertensive medications during the Run-in Period as assessed at the Randomization Visit (Visit 3). • Subject has taken a mineralocorticoid receptor antagonist (MRA), a potassium-sparing diuretic, or chronic potassium supplements during the 4 weeks before the Screening Visit (Visit 1). • Subject has taken potassium binders for the treatment of hyperkalemia during the 3 months before the Screening Visit (Visit 1). • Subject has taken a strong CYP3A4 inducer or strong CYP3A4 inhibitor during the 7 days before the Randomization Visit (Visit 3).

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate the efficacy and durability of KBP-5074 in reducing systolic blood pressure (SBP). ;Secondary Objective: The secondary objectives of this study are: • To evaluate the effect of KBP-5074 on diastolic blood pressure (DBP) and urine albumin:creatinine ratio (UACR); • To evaluate the safety and tolerability of KBP-5074. ;Primary end point(s): The primary endpoint for efficacy is change in seated trough cuff SBP from baseline to Week 12. The second key endpoint for durability is change in seated trough cuff SBP from Week 48 to Week 52. ;Timepoint(s) of evaluation of this end point: From baseline to Week 12 From Week 48 to Week 52	—

Measure

Time frame

Main Objective: The primary objective of this study is to evaluate the efficacy and durability of KBP-5074 in reducing systolic blood pressure (SBP). ;Secondary Objective: The secondary objectives of this study are: • To evaluate the effect of KBP-5074 on diastolic blood pressure (DBP) and urine albumin:creatinine ratio (UACR); • To evaluate the safety and tolerability of KBP-5074. ;Primary end point(s): The primary endpoint for efficacy is change in seated trough cuff SBP from baseline to Week 12. The second key endpoint for durability is change in seated trough cuff SBP from Week 48 to Week 52. ;Timepoint(s) of evaluation of this end point: From baseline to Week 12 From Week 48 to Week 52

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Secondary

Measure	Time frame
Secondary end point(s): The key secondary efficacy endpoints for the study are: • Change in seated trough cuff SBP from baseline to Week 24; • Changes in seated trough cuff DBP from baseline to Week 12 and Week 24; • Changes in UACR from baseline to Week 12 and Week 24 for subjects with UACR =30 mg/g at baseline. Other secondary efficacy endpoints for the study are: • Changes in seated trough cuff SBP and DBP from baseline to Week 48; • Percentage changes in UACR from baseline to Week 12 and Week 24 for subjects with UACR =30 mg/g at baseline; • Changes and percentage changes in UACR from baseline to Week 12, Week 24, and Week 48 for subjects with macroalbuminuria (defined as UACR =300 mg/g) at baseline; • Changes and percentage changes in UACR from baseline to Week 12, Week 24, and Week 48 for subjects with microalbuminuria (defined as UACR =30 and 5.0 to <5.6 mmol/L, =5.6 to <6.0 mmol/L, and =6.0 mmol/L by central laboratory results; • Changes in serum potassium levels from baseline to Week 12, Week 24, and Week 48 by central laboratory results; • Changes in eGFR from baseline to Week 12, Week 24, and Week 48 by central laboratory results; • Incidence of sustained decreases in eGFR of =30% from baseline by central laboratory results (an eGFR decrease of =30% from baseline will be considered sustained if the eGFR reduction is still =30% from baseline at least 4 weeks after the initial measurement); • Change in serum potassium levels from Week 48 to Week 52 by central laboratory results; • Change in eGFR from Week 48 to Week 52 by central laboratory results. ;Timepoint(s) of evaluation of this end point: Throughout the study	—

Measure

Time frame

Secondary end point(s): The key secondary efficacy endpoints for the study are: • Change in seated trough cuff SBP from baseline to Week 24; • Changes in seated trough cuff DBP from baseline to Week 12 and Week 24; • Changes in UACR from baseline to Week 12 and Week 24 for subjects with UACR =30 mg/g at baseline. Other secondary efficacy endpoints for the study are: • Changes in seated trough cuff SBP and DBP from baseline to Week 48; • Percentage changes in UACR from baseline to Week 12 and Week 24 for subjects with UACR =30 mg/g at baseline; • Changes and percentage changes in UACR from baseline to Week 12, Week 24, and Week 48 for subjects with macroalbuminuria (defined as UACR =300 mg/g) at baseline; • Changes and percentage changes in UACR from baseline to Week 12, Week 24, and Week 48 for subjects with microalbuminuria (defined as UACR =30 and 5.0 to <5.6 mmol/L, =5.6 to <6.0 mmol/L, and =6.0 mmol/L by central laboratory results; • Changes in serum potassium levels from baseline to Week 12, Week 24, and Week 48 by central laboratory results; • Changes in eGFR from baseline to Week 12, Week 24, and Week 48 by central laboratory results; • Incidence of sustained decreases in eGFR of =30% from baseline by central laboratory results (an eGFR decrease of =30% from baseline will be considered sustained if the eGFR reduction is still =30% from baseline at least 4 weeks after the initial measurement); • Change in serum potassium levels from Week 48 to Week 52 by central laboratory results; • Change in eGFR from Week 48 to Week 52 by central laboratory results. ;Timepoint(s) of evaluation of this end point: Throughout the study

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Countries

Bosnia and Herzegovina, Bulgaria, Canada, China, Croatia, Czechia, Czech Republic, Georgia, Germany, Hong Kong, Hungary, Korea, Republic of, Latvia, Lithuania, Malaysia, Poland, Serbia, South Africa, Spain, Taiwan, United States

Contacts

Public ContactKBP Biosciences Clinical Trial Cont

KBP BioSciences PTE. Ltd.

kbp5074clarion-ckd@kbpbiosciences.com1(609) 874-0416

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026