Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe CKD (Clarion-CKD)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04968184 |
Recruitment Status :
Active, not recruiting
First Posted : July 20, 2021
Last Update Posted : February 26, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | July 7, 2021 | ||||
First Posted Date ICMJE | July 20, 2021 | ||||
Last Update Posted Date | February 26, 2024 | ||||
Actual Study Start Date ICMJE | November 5, 2021 | ||||
Actual Primary Completion Date | January 30, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe CKD | ||||
Official Title ICMJE | A Phase 3 Randomized Double-Blind Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of KBP-5074 Mineralocorticoid Receptor Antagonist in Subjects With Uncontrolled Hypertension and Moderate or Severe (Stage 3b/4) CKD | ||||
Brief 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. | ||||
Detailed Description | Participants in this study will be recruited, screened, and enrolled at approximately 140 study sites globally. The study will consist of the following periods:
During, 24-week Double-blind Treatment Period, 24-week Open-label Treatment Period, and at 4-week Randomized Double-blind Withdrawal Period, the background antihypertensive medications change may or may not be allowed. At Double-blind Treatment Period, eligible participants will be randomly assigned in a 1:1 ratio to KBP-5074 0.25 mg or matching placebo once daily (QD). At the Randomized Double-blind Withdrawal Period, participants who meet the randomized withdrawal criteria will be randomly assigned in a 1:1 ratio to continue their current KBP-5074 dose at the end of the Open-label Treatment Period or matching placebo QD. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: All individuals directly involved in the conduct of the study, including participants, Investigators, site staff, clinical research organization (CRO) personnel, and Sponsor study personnel, will remain blinded to treatment assignments until all participants have completed the Week 56 end of study (EOS) Visit (Visit 17) and the database locked in preparation. Primary Purpose: Treatment
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Condition ICMJE | Chronic Kidney Diseases | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
652 | ||||
Original Estimated Enrollment ICMJE |
600 | ||||
Estimated Study Completion Date ICMJE | January 15, 2025 | ||||
Actual Primary Completion Date | January 30, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, Bosnia and Herzegovina, Bulgaria, Canada, China, Croatia, Czechia, Georgia, Germany, Hong Kong, Hungary, Israel, Korea, Republic of, Latvia, Lithuania, Malaysia, Poland, Serbia, South Africa, Spain, Taiwan, United States | ||||
Removed Location Countries | Belgium, Denmark, Netherlands, Turkey, Ukraine | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT04968184 | ||||
Other Study ID Numbers ICMJE | KBP5074-3-001 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | KBP Biosciences | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | KBP Biosciences | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | KBP Biosciences | ||||
Verification Date | February 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |