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KBP-5074 for High Blood Pressure and Chronic Kidney Disease (Clarion-CKD Trial)
Phase 3
Waitlist Available
Research Sponsored by KBP Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
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)
Must not have
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 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 12, week 24, and week 48
Awards & highlights
Summary
This trial will study whether KBP-5074 is effective and safe in adults with stage 3b/4 CKD and uncontrolled hypertension.
Who is the study for?
Adults with stage 3b or 4 chronic kidney disease (CKD) and uncontrolled high blood pressure despite taking two or more antihypertensive medications. Participants should have a BMI between ≥19 to <45 kg/m^2, stable medication doses for at least four weeks, and systolic blood pressure between ≥140 and <180 mm Hg.Check my eligibility
What is being tested?
The trial is testing the effectiveness of KBP-5074 compared to a placebo in managing hypertension in patients with moderate to severe CKD. It's a phase 3 study where participants are randomly assigned to either the drug or placebo group without knowing which one they receive.See study design
What are the potential side effects?
While specific side effects of KBP-5074 aren't listed here, common ones may include changes in potassium levels, impacts on kidney function, dizziness due to lowered blood pressure, and potential interactions with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is moderately to severely reduced.
Select...
My high blood pressure is not controlled even though I am on two or more medications.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been taking a specific water pill or potassium supplement for the last 4 weeks.
Select...
I did not follow the medication plan during the trial's initial phase.
Select...
I have not taken strong CYP3A4 drugs in the week before my visit.
Select...
I was hospitalized for high potassium levels within the last 3 months.
Select...
My blood pressure was 180 or higher before starting the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to week 12, week 24, and week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 12, week 24, and week 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in seated trough cuff SBP from Week 48 to Week 52
Change in seated trough cuff SBP from baseline to Week 12
Secondary outcome measures
Change in UACR from Week 48 to Week 52
Change in seated trough cuff DBP from Week 48 to Week 52
Change in seated trough cuff SBP from baseline to Week 24
+8 moreSide effects data
From 2017 Phase 1 trial • 11 Patients • NCT028372379%
increased creatinine
9%
procedural hypotension
9%
hyperkalemia
9%
fatigue
9%
metabolic acidosis
9%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
KBP-5074
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: KBP-5074Experimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
KBP-5074
2020
Completed Phase 1
~130
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Chronic Kidney Disease (CKD) include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), and mineralocorticoid receptor antagonists (MRAs) like spironolactone and KBP-5074. MRAs work by blocking the action of aldosterone, a hormone that can cause sodium retention, potassium loss, and fibrosis in the kidneys.
By inhibiting aldosterone, MRAs help reduce blood pressure, decrease proteinuria, and prevent further kidney damage. This is particularly important for CKD patients as it helps slow the progression of the disease and reduces the risk of cardiovascular events, which are common complications in this population.
Evidence-Based Medical Therapy in Patients With Heart Failure With Reduced Ejection Fraction and Chronic Kidney Disease.Aldosterone antagonists for people with chronic kidney disease requiring dialysis.Aldosterone Antagonists Reduce the Risk of Cardiovascular Mortality in Dialysis Patients: A Meta-Analysis.
Evidence-Based Medical Therapy in Patients With Heart Failure With Reduced Ejection Fraction and Chronic Kidney Disease.Aldosterone antagonists for people with chronic kidney disease requiring dialysis.Aldosterone Antagonists Reduce the Risk of Cardiovascular Mortality in Dialysis Patients: A Meta-Analysis.
Find a Location
Who is running the clinical trial?
KBP BiosciencesLead Sponsor
12 Previous Clinical Trials
450 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been taking a specific water pill or potassium supplement for the last 4 weeks.I did not follow the medication plan during the trial's initial phase.I have not taken strong CYP3A4 drugs in the week before my visit.My high blood pressure is not controlled even though I am on two or more medications.My kidney function is moderately to severely reduced.Your blood pressure is consistently higher than 140 mm Hg during the screening and run-in period visits.I have been taking medication to lower my potassium levels for the last 3 months.Your body mass index (BMI) should be between 19 and 45.Your blood potassium level was too high in the last 2 weeks.I have not taken any traditional Chinese medication in the last 28 days.I was hospitalized for high potassium levels within the last 3 months.I am on 2 or more blood pressure medications that have been stable for at least 4 weeks.My blood pressure was 180 or higher before starting the trial.Your blood test showed that you have high potassium levels.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: KBP-5074
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Kidney Disease Patient Testimony for trial: Trial Name: NCT04968184 — Phase 3
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