Renal Denervation for High Blood Pressure

(TARGET BP I Trial)

Not currently recruiting at 4 trial locations

Overseen By Farrell Mendelsohn, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ablative Solutions, Inc.

Must be taking: Antihypertensives

Must not be taking: NSAIDs, Immunosuppressives, Steroids

Disqualifiers: Renal abnormalities, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 10

Duration: Procedure date (day 0)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if renal denervation, using the Peregrine System Kit, can assist individuals with high blood pressure not well-controlled by medication. The procedure involves infusing a small amount of dehydrated alcohol near the arteries leading to the kidneys to assess its effect on lowering blood pressure. Participants will receive either the actual procedure or a sham procedure, similar to a placebo, for comparison. Suitable candidates have high blood pressure readings and take two to five blood pressure medications but still struggle to manage their condition. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it requires participants to be on 2 to 5 blood pressure medications. It seems you may continue your current blood pressure medications if they fall within this range.

What prior data suggests that the Peregrine System Kit is safe for renal denervation?

Research has shown that using the Peregrine System Kit with dehydrated alcohol for kidney treatment has been well-tolerated in past studies. Several trials comparing it to a placebo have demonstrated that this treatment is safe to use alongside other treatments for high blood pressure. Specifically, studies have found the procedure generally safe, with no major side effects directly linked to it. Long-term results, up to 12 months after the procedure, also confirm its safety, meeting safety standards in trials for patients with difficult-to-control high blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatment involving the Peregrine System Kit for high blood pressure because it offers a novel approach through renal denervation. Unlike current options such as medications that lower blood pressure by targeting the heart or blood vessels, this treatment directly infuses dehydrated alcohol into the perivascular space of the renal arteries using a catheter. This method aims to reduce nerve activity around the arteries, potentially offering a more targeted and long-lasting effect. The unique delivery through the Peregrine Catheter provides a minimally invasive alternative, which could be a game-changer for patients who don't respond well to existing medications.

What evidence suggests that the Peregrine System Kit is effective for high blood pressure?

Research has shown that alcohol-mediated renal denervation can help lower blood pressure in patients. In this trial, participants in the experimental group will receive this treatment using the Peregrine System Kit, which delivers a small amount of alcohol to the arteries in the kidneys. This process reduces nerve activity that contributes to high blood pressure. Studies have found that this treatment can safely and effectively reduce high blood pressure for up to 12 months. Long-term results indicate a modest but consistent drop in blood pressure after the treatment. Overall, evidence suggests that this approach may be a useful option for people with resistant hypertension, which is high blood pressure that doesn’t respond well to standard treatments. ^{1 3 4 6 7}

Who Is on the Research Team?

David Kandzari, MD

Principal Investigator

Piedmont Heart Institute

Felix Mahfoud, MD

Principal Investigator

Klinik fur Innere Medizin III

Michael Weber, MD

Principal Investigator

SUNY Downstate Medical

Atul Pathak, MD

Principal Investigator

Clinique Pasteur

Are You a Good Fit for This Trial?

This trial is for adults with high blood pressure, specifically those with a systolic reading between 150-180 mmHg and diastolic above 90 mmHg while on 2-5 blood pressure medications. Participants must also have certain ambulatory blood pressure readings. Those with kidney issues, sleep apnea, severe heart conditions, recent major cardiovascular events or who are pregnant/lactating cannot join.

Inclusion Criteria

My average blood pressure is between 150/90 and 180/90 mmHg while on 2-5 blood pressure medications.

Your average blood pressure over 24 hours is between 135 and 170 mmHg with at least 70% of the readings being accurate.

Exclusion Criteria

I have been diagnosed with sleep apnea.

I have severe heart or lung conditions.

My kidney function is low or I am on long-term dialysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive renal denervation with the Peregrine System Kit or undergo a sham procedure

Procedure date (day 0)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Multiple visits at 5-day, 4 weeks, 8 weeks, 3 months

Extended Follow-up

Long-term monitoring of participants for adverse events and blood pressure changes

3 years

Visits at 4 months, 5 months, 6 months, 1 year, 2 years, and 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Dehydrated alcohol
• Peregrine System Kit

Trial Overview The TARGET BP I Trial is testing the effectiveness of renal denervation using the Peregrine System Kit compared to a sham procedure (no real treatment). Participants will be randomly assigned to either receive the actual intervention or a fake one without knowing which group they're in.

How Is the Trial Designed?

Group I: Treated with Peregrine System Kit Experimental Treatment 1 Intervention

The experimental group will receive an infusion of Dehydrated Alcohol Injection, USP into the perivascular space of the renal arteries with the Peregrine Catheter. A total of 0.6mL of the alcohol will be delivered to the perivascular space of each renal artery. The drug will only be delivered once to each renal artery during the treatment procedure.

Group II: Renal Angiography Only (Sham Procedure) Placebo Group 1 Intervention

The sham control group will only have diagnostic renal angiography performed. There will be no insertion of the Peregrine Catheter and no alcohol infusion (i.e. no renal denervation).

Who Is Running the Clinical Trial?

Ablative Solutions, Inc.

Lead Sponsor

Trials

4

Recruited

710+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8452324/

Long-Term Results up to 12 Months After Catheter-Based ... This article describes the final, 12-month follow-up data on the safety and efficacy of alcohol-mediated renal denervation in these patients.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02910414

Study Details | NCT02910414 | TARGET BP I Clinical Trial This trial is intended to evaluate the safety and efficacy of the Peregrine Catheter when used to deliver a 0.6 mL volume of alcohol to the perivascular area of ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.121.011293

Catheter-Based Alcohol-Mediated Renal Denervation for ... Long-term results up to 12 months after catheter-based alcohol-mediated renal denervation for treatment of resistant hypertension.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002870321001447

Trial designs Catheter-based alcohol-mediated renal ... The TARGET BP trials are randomized, blinded, sham-controlled trials designed to assess the safety and efficacy of alcohol-mediated RDN for the treatment of ...

5. ablativesolutions.com ablativesolutions.com/in/health-care-providers/investigational-peregrine-kit/

Investigational Peregrine Kit – Ablative Solutions The randomized controlled phase is complete, and results have demonstrated that alcohol-mediated renal denervation is safe and modest blood pressure lowering ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11239130/

Renal Denervation for Hypertension: The Current ... Multiple placebo-controlled randomized studies have shown the safety and efficacy of renal denervation as an adjunctive therapy.

7. clinicaltrialsarena.com clinicaltrialsarena.com/news/ablatives-renal-denervation-kit-hits-primary-endpoint-in-trial/

Ablative's renal denervation kit hits primary endpoint in trial The pivotal trial for Ablative's Peregrine system met its primary endpoint in patients with uncontrolled hypertension.