The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 9 for:    KBP-5074
Previous Study | Return to List | Next Study

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
Sponsor:
Information provided by (Responsible Party):
KBP Biosciences

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Drug: Placebo Drug: KBP-5074 Phase 3

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:

  1. Pretreatment Phase: This will include prescreening assessment and screening period of up to 4 weeks and 2-week Open-label placebo Run-In period.
  2. A 24-week Double-blind Treatment Period (Randomization to Week 24) will include: An initial 12-week (Randomization to Week 12) and second 12-week (Week 12 to Week 24) treatment period and a second 12-week treatment period (Week 12 to Week 24), during both the periods study drug will be titrated.
  3. A 24-week Open-label Treatment Period (Week 24 to Week 48) during which eligible participants will receive Open-label KBP-5074.
  4. A 4-week Randomized Double-blind Withdrawal Period (Week 48 to Week 52) during which eligible participants will be randomized to continue their current KBP-5074 dose at the end of Open-label treatment or receive matching placebo for 4 weeks.
  5. A 4-week post-treatment Follow-Up Period (Week 52 to Week 56).

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 652 participants
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
Official Title: 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
Actual Study Start Date : November 5, 2021
Actual Primary Completion Date : January 30, 2024
Estimated Study Completion Date : January 15, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Placebo
All eligible participants will receive KBP-5074 matching placebo, for approximately 2 weeks, during the Open-label placebo Run-In period, then up to 24 weeks during the Double-blind treatment Period and during the Open-label treatment period, and thereafter for 4 weeks, during the randomized Double-blind withdrawal period.
 Drug: Placebo
Participants will orally receive placebo matching to KBP-5074 tablets QD.
Experimental: KBP-5074
All eligible participants will receive KBP-5074, for up to 24 weeks during the Double-blind treatment Period and during the Open-label treatment period. Thereafter, eligible participants will continue current dose of KBP-5074 at the end of the Open-label treatment period.
 Drug: KBP-5074
Participants will orally receive KBP-5074 tablets, from 0.25 mg to a maximum dose of 0.5-mg QD.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in seated trough cuff SBP from baseline to Week 12 [ Time Frame: From baseline to Week 12 ]
    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.

  2. Change in seated trough cuff SBP from Week 48 to Week 52 [ Time Frame: Week 48 to Week 52 ]
    Durability of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP for the KBP-5074 dose regimen compared to placebo, will be evaluated.


Secondary Outcome Measures :
  1. Change in seated trough cuff SBP from baseline to Week 24 [ Time Frame: From baseline to Week 24 ]
    Efficacy and durability of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP, will be evaluated.

  2. Changes in seated trough cuff diastolic blood pressure (DBP) from baseline to Week 12 and Week 24 [ Time Frame: From baseline to Week 12 and Week 24 ]
    Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP, will be evaluated.

  3. Changes in seated trough cuff SBP and DBP from baseline to Week 48 [ Time Frame: From baseline to Week 48 ]
    Effect of KBP-5074 on SBP and DBP by assessing change in seated trough cuff SBP and DBP, will be evaluated.

  4. Changes in urinary albumin: creatinine ratio (UACR) from baseline to Week 12 and Week 24 for participants with UACR ≥30 mg/g at baseline [ Time Frame: From baseline to Week 12 and Week 24 ]
    Effect of KBP-5074 on UACR by assessing changes in UACR for participants with UACR ≥30 mg/g at baseline, will be evaluated.

  5. Percentage changes in UACR from baseline to Week 12 and Week 24 for participants with UACR ≥30 mg/g at baseline [ Time Frame: From baseline to Week 12 and Week 24 ]
    Effect of KBP-5074 on UACR by assessing percentage changes in UACR for participants with UACR ≥30 mg/g at baseline, will be evaluated.

  6. Changes in UACR from baseline to Week 12, Week 24, and Week 48 [ Time Frame: From baseline to Week 12, Week 24, and Week 48 ]
    Effect of KBP-5074 on UACR by assessing changes in UACR for participants with macroalbuminuria (defined as UACR ≥300 mg/g) and microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, will be evaluated.

  7. Percentage changes in UACR from baseline to Week 12, Week 24, and Week 48 [ Time Frame: From baseline to Week 12, Week 24, and Week 48 ]
    Effect of KBP-5074 on UACR by assessing percentage changes in UACR for participants with macroalbuminuria (defined as UACR ≥300 mg/g) and microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, will be evaluated.

  8. Change in seated trough cuff DBP from Week 48 to Week 52 [ Time Frame: Week 48 to Week 52 ]
    Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP, will be evaluated.

  9. Change in UACR from Week 48 to Week 52 [ Time Frame: Week 48 to Week 52 ]
    Effect of KBP-5074 on UACR by assessing changes in UACR for participants with UACR ≥30 mg/g, macroalbuminuria (defined as UACR ≥300 mg/g) and microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, will be evaluated.

  10. Percentage change in UACR from Week 48 to Week 52 [ Time Frame: Week 48 to Week 52 ]
    Effect of KBP-5074 on UACR by assessing percentage changes in UACR for participants with UACR ≥30 mg/g, macroalbuminuria (defined as UACR ≥300 mg/g) and microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, will be evaluated.

  11. Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Screening (Week -6 to -2) until EOS (Week 56) or Unscheduled visit or end of treatment or early termination ]
    The safety and tolerability of KBP-5074,will be evaluated.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04968184


Locations
Show Show 215 study locations
Sponsors and Collaborators
KBP Biosciences
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: KBP Biosciences
ClinicalTrials.gov Identifier: NCT04968184    
Other Study ID Numbers: KBP5074-3-001
First Posted: July 20, 2021    Key Record Dates
Last Update Posted: February 26, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by KBP Biosciences:
Stage 3b/4 chronic kidney disease
Hypertension
Uncontrolled Hypertension
 Blood pressure
Mineralocorticoid Receptor Antagonist
Randomized withdrawal
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Hypertension
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes