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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 12, week 24, and week 48
Awards & highlights
Clarion-CKD Trial 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.
Clarion-CKD Trial 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.
Clarion-CKD 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%
hyperkalemia
9%
procedural hypotension
9%
fatigue
9%
metabolic acidosis
9%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
KBP-5074
Clarion-CKD 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
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the goal of this research?
"According to the clinical trial sponsor's report, KBP Biosciences, the primary objective is Change in seated trough cuff SBP from Week 48 to 52. This will be measured over a From baseline to Week 12 interval. Additionally, this study intends on measuring secondary outcomes including Number of participants with adverse events (AEs) and serious adverse events (SAEs) which is defined as The safety and tolerability of KBP-5074,will be evaluated., Percentage changes in UACR from baseline to Week 12 and 24 for participants with UACR ≥30 mg/g at baseline which is defined as Effect of KBP"
Answered by AI
In how many different medical clinics is this medical study being run today?
"Patients are currently being accepted at Vanderbilt University School of Medicine (VUSM) - Vanderbilt Center for Kidney Disease (VCKD) in Nashville, Tennessee, Nephrology Consultants, LLC in Huntsville, Alabama, Central Florida Heart Center in Ocala, California as well as 82 other clinical trial sites."
Answered by AI
Are new patients still being enrolled in this research project?
"The current status of this trial, as reflected on clinicaltrials.gov, is that it is seeking participants. This particular study was first made public on November 5th, 2021 and the most recent update was on October 21st, 2022."
Answered by AI
How many test subjects are needed for this experiment?
"In order for this trial to move forward, 600 willing and eligible patients must be recruited from multiple sites - such as Vanderbilt University School of Medicine (VUSM) - Vanderbilt Center for Kidney Disease (VCKD) in Nashville, Tennessee and Nephrology Consultants, LLC in Huntsville, Alabama."
Answered by AI
What has been KBP-5074's effect on patients in clinical trials?
"There is already some evidence to support KBP-5074's efficacy, as well as multiple rounds of data attesting to its safety. Consequently, our team has given it a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
Massachusetts
Texas
What site did they apply to?
Aventiv Research, Inc
Massachusetts General Hospital (MGH) - Renal Associates Clinic
DaVita Clinical Research Houston
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Hoping this trial will address my condition. I have Stage 3a Chronic Kidney Disease. Am I eligible?
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
I am I eligible with Stage 3a CKD?
PatientReceived 2+ prior treatments
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