The trial is taking place at:
N

Noble Clinical Research | Tucson, AZ

Veeva-enabled site

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

K

KBP Biosciences

Status and phase

Active, not recruiting
Phase 3

Conditions

Chronic Kidney Diseases

Treatments

Drug: KBP-5074
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04968184
KBP5074-3-001

Details and patient eligibility

About

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.

Full 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: Pretreatment Phase: This will include prescreening assessment and screening period of up to 4 weeks and 2-week Open-label placebo Run-In period. 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. A 24-week Open-label Treatment Period (Week 24 to Week 48) during which eligible participants will receive Open-label KBP-5074. 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. 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.

Enrollment

652 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

652 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo
KBP-5074
Experimental group
Description:
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.
Treatment:
Drug: KBP-5074

Trial contacts and locations

216

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Central trial contact

KBP Biosciences Clinical Trials Contact

Data sourced from clinicaltrials.gov

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