KBP-5074 for High Blood Pressure and Chronic Kidney Disease

(Clarion-CKD Trial)

Recruiting at 316 trial locations

Overseen By KBP Biosciences Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: KBP Biosciences

Must be taking: Antihypertensives

Must not be taking: MRAs, Potassium-sparing diuretics

Disqualifiers: Hyperkalemia, High blood pressure, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

652 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you continue taking your current blood pressure medications without any dose changes for at least 4 weeks before the screening. However, you must stop taking certain medications like mineralocorticoid receptor antagonists, potassium-sparing diuretics, and some others before joining the trial.

What data supports the effectiveness of the drug KBP-5074 for high blood pressure and chronic kidney disease?

Research shows that KBP-5074, a non-steroidal drug, can lower blood pressure in patients with chronic kidney disease and resistant hypertension without causing high potassium levels, which is a common side effect of similar drugs. ^{1 2 3 4 5}

Is KBP-5074 safe for humans?

KBP-5074, also known as Ocedurenone, is being studied for its safety in people with chronic kidney disease and high blood pressure. It is a non-steroidal treatment that aims to lower blood pressure without causing high potassium levels, a common side effect of similar treatments. ^{1 2 3 4 6}

How is the drug KBP-5074 different from other treatments for high blood pressure and chronic kidney disease?

KBP-5074 is unique because it is a non-steroidal mineralocorticoid receptor antagonist, which means it can help lower blood pressure in patients with chronic kidney disease without causing high potassium levels, a common side effect of other similar drugs like spironolactone. ^{1 2 3 7 8}

What is the purpose of this trial?

This trial is testing KBP-5074, a new drug, in adults with severe kidney disease and high blood pressure. The goal is to see if it can better manage their blood pressure and improve kidney health compared to their current treatments.

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Open-label Placebo Run-In

Participants receive open-label placebo to establish baseline conditions

2 weeks

1 visit (in-person)

Double-blind Treatment

Participants receive either KBP-5074 or placebo in a double-blind manner

24 weeks

Regular visits (in-person)

Open-label Treatment

Participants receive open-label KBP-5074

24 weeks

Regular visits (in-person)

Randomized Double-blind Withdrawal

Participants are randomized to continue KBP-5074 or switch to placebo

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• KBP-5074
• Placebo

Trial Overview 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.

Participant Groups

Group I: KBP-5074 Experimental Treatment 1 Intervention

Open-label Placebo Run-In period: All eligible participants will receive matching placebo, for approximately 2 weeks during the Open-label placebo Run-In period. Double-blind Treatment Period: All eligible participants will receive KBP-5074, from week 2 thru week 24 during the Double-blind Treatment Period Open-label Treatment Period: All eligible participants will receive KBP-5074, from week 24 thru week 48 during the Open label Treatment Period Randomized Double-blind Withdrawal Period: All eligible participants will be randomized to either continue their current KBP-5074 dose at the end of the Open-Label Treatment Period or receive matching placebo from week 48 thru week 52. Follow up Period: All participants will discontinue matching placebo/KBP-5074 and be followed for safety until end of study visit from week 52 to week 56.

Group II: Placebo Placebo Group 1 Intervention

Open-label Placebo Run-In Period: All eligible participants will receive matching placebo, for approximately 2 weeks, during the Open-label placebo Run-In period. Double-blind Treatment Period: All eligible participants will receive matching placebo, from week 2 thru week 24 during the Double-blind treatment Period Open-label Treatment Period: All eligible participants will receive KBP-5074, from week 24 thru week 48 during the Open label Treatment Period Randomized Double-blind Withdrawal Period: All eligible participants will be randomized to either continue their current KBP-5074 dose at the end of the Open-Label Treatment Period or receive matching placebo from week 48 thru week 52. Follow up Period: All participants will discontinue matching placebo/KBP-5074 and be followed for safety until end of study visit from week 52 to week 56.

Who Is Running the Clinical Trial?

KBP Biosciences

Lead Sponsor

Trials

13

Recruited

1,100+

References

1. England pubmed.ncbi.nlm.nih.gov

An evaluation of KBP-5074 in advanced chronic kidney disease with uncontrolled hypertension. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Ocedurenone: Subgroup Analysis of the BLOCK-CKD Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Mineralocorticoid Receptor Antagonists for Hypertension Management in Advanced Chronic Kidney Disease: BLOCK-CKD Trial. [2021]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Physician perceptions of blood pressure control in patients with chronic kidney disease and target blood pressure achievement rate. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Meaningful measurement: developing a measurement system to improve blood pressure control in patients with chronic kidney disease. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Potential implications of the 2021 KDIGO blood pressure guideline for adults with chronic kidney disease in the United States. [2022]

7. China pubmed.ncbi.nlm.nih.gov

[Characteristic of blood pressure profile in elderly hypertensive patients with chronic kidney disease: a tertiary hospital-based study]. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Recent advances in the management of secondary hypertension: chronic kidney disease. [2022]