KBP-5074 for High Blood Pressure and Chronic Kidney Disease

(Clarion-CKD Trial)

Recruiting at 339 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, KBP-5074, to determine its effectiveness for people with chronic kidney disease (CKD) and difficult-to-control high blood pressure. The study compares KBP-5074 with a placebo (a pill with no active medicine) to assess its efficacy and safety. It suits individuals with stage 3b or 4 CKD who are taking at least two medications for high blood pressure but still have readings of 140/90 or higher. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that KBP-5074 is likely to be safe for humans?

Research shows that KBP-5074 has been tested for safety in people with chronic kidney disease and high blood pressure. Earlier studies found it effectively lowers blood pressure. However, some participants experienced high potassium levels in their blood, known as hyperkalemia, which is important to consider when evaluating this treatment.

Although researchers are still studying this treatment, its presence in a later phase of trials suggests some evidence of safety. Discuss any potential risks with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for high blood pressure and chronic kidney disease, like ACE inhibitors or ARBs, work by relaxing blood vessels and reducing fluid retention. But KBP-5074 works differently, targeting the mineralocorticoid receptor more selectively. This approach aims to reduce side effects often seen with similar drugs, such as hyperkalemia (high potassium levels). Researchers are excited because this selective action may provide effective blood pressure and kidney protection with fewer complications.

What evidence suggests that KBP-5074 might be an effective treatment for high blood pressure and chronic kidney disease?

Research has shown that KBP-5074, which participants in this trial may receive, effectively lowers blood pressure in individuals with advanced chronic kidney disease and difficult-to-control high blood pressure. One study found that this treatment reduced systolic blood pressure, the top number in a blood pressure reading. KBP-5074 blocks certain hormones that can raise blood pressure. Some patients might experience high potassium levels, known as hyperkalemia, as a side effect. Overall, these findings suggest that KBP-5074 can help manage blood pressure in those with both kidney disease and high blood pressure. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.121.17073

Effect of KBP-5074 on Blood Pressure in Advanced ... We conclude that KBP-5074 effectively lowers blood pressure with some risk of hyperkalemia in individuals with advanced chronic kidney disease and uncontrolled ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33966452/

Effect of KBP-5074 on Blood Pressure in Advanced ... Effect of KBP-5074 on Blood Pressure in Advanced Chronic Kidney Disease: Results of the BLOCK-CKD Study. Hypertension. 2021 Jul;78(1):74-81.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03574363

Phase 2b Study of KBP-5074 in Subjects With Uncontrolled ... This is a Phase 2 randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy, safety, and pharmacokinetics of KBP-5074 in patients ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/13543784.2021.1985462

An evaluation of KBP-5074 in advanced chronic kidney ... Although not directly compared to finerenone, it appears to be more effective in lowering systolic blood pressure. KBP-5074 is a highly selective nonsteroidal ...

5. academic.oup.com academic.oup.com/ajh/article/36/11/612/7227048

Subgroup Analysis of the BLOCK-CKD Study - Oxford Academic Ocedurenone (KBP-5074), a nonsteroidal mineralocorticoid receptor antagonist, is documented to lower blood pressure in patients with stage 3b/4 chronic kidney ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10570658/

Efficacy and Safety of Ocedurenone: Subgroup Analysis of the ... Ocedurenone (KBP-5074), a nonsteroidal mineralocorticoid receptor antagonist, is documented to lower blood pressure in patients with stage 3b/4 chronic kidney ...

7. medrxiv.org medrxiv.org/content/10.1101/2020.05.12.20053314v1.full.pdf

Safety and Pharmacokinetics of a Novel Non-Steroidal ... The results from these studies provided informative PK and safety data and support further evaluation of KBP-5074 in ESRD in both HD or non-HD ...