140 Participants NeededMy employer runs this trial

Tonlamarsen for High Blood Pressure

(KARDINAL-ASH Trial)

Recruiting at 10 trial locations
KC
Overseen ByKardigan Clinical Study Information Team
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Kardigan, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests tonlamarsen, a drug designed to lower high blood pressure in individuals recently discharged from the hospital after a severe blood pressure crisis. Participants will receive either the actual drug or a placebo (a harmless, inactive substance) to evaluate tonlamarsen's effectiveness in reducing blood pressure. It suits individuals who recently experienced severe high blood pressure and have other heart or kidney issues. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that tonlamarsen is likely to be safe for humans?

A previous study found that tonlamarsen is generally safe for people. Researchers discovered that administering tonlamarsen every four weeks did not cause serious side effects in patients with high blood pressure. Although more research is needed, these findings support its safety for human use.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for high blood pressure, which often include oral medications like ACE inhibitors, beta-blockers, or diuretics, Tonlamarsen is administered through a subcutaneous injection. This approach can offer more consistent drug delivery and potentially improve patient adherence compared to daily pills. Tonlamarsen also represents a new class of medication that may provide alternative pathways to lower blood pressure, which can be particularly exciting for patients who haven't responded well to traditional options. Researchers are optimistic that this novel delivery method and mechanism of action could lead to more effective blood pressure management.

What evidence suggests that tonlamarsen might be an effective treatment for high blood pressure?

Research has shown that tonlamarsen can help lower blood pressure in adults with uncontrolled high blood pressure. In earlier studies, participants who took tonlamarsen experienced an average blood pressure reduction of 6.7 mm Hg. This trial will test tonlamarsen, which reduces a protein called angiotensinogen, potentially affecting blood pressure by up to 67%. These results suggest that tonlamarsen might be effective for individuals with severe high blood pressure, although outcomes have been mixed. While the drug significantly reduces the angiotensinogen protein, its effect on blood pressure can vary.12467

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who were just sent home from the hospital after being treated for a sudden, severe spike in blood pressure. Participants must still have high blood pressure and also have heart or kidney problems.

Inclusion Criteria

* Recently discharged from the hospital to home within the past 3 days during which evaluation and/or treatment of acute severe hypertension (documented systolic blood pressure \>180 mmHg and/or diastolic \>110 mmHg) occurred, as measured by a healthcare provider within the 24 hours preceding hospitalization or during the initial 24 hours of hospitalization
* At Screening and Randomization visit, average systolic blood pressure \> 145 mmHg
I have diagnosed heart or kidney conditions.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive monthly doses of tonlamarsen or placebo for approximately 3 months

12 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Tonlamarsen

Trial Overview

The study compares a new drug called tonlamarsen to a placebo (inactive treatment) to see if it can safely lower blood pressure in people recently hospitalized for very high blood pressure. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: TonlamarsenExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kardigan, Inc.

Lead Sponsor

Trials
1
Recruited
700+

Citations

Study of Efficacy and Safety of Tonlamarsen in Participants ...

The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who were recently discharged from the hospital, ...

The KARDINAL Phase 2 Randomized Clinical Trial

Among individuals with uncontrolled hypertension, monthly tonlamarsen administration was more effective at lowering plasma angiotensinogen ...

Tonlamarsen for Patients With Uncontrolled Hypertension

Blood pressure was reduced by a mean of 6.7 mm Hg for patients who received one dose of tonlamarsen (95% CI, -9.8 to -3.5) and 6.7 mm Hg for ...

Kardigan Announces Positive Phase 2 Data for ...

Patients treated with tonlamarsen experienced statistically significant reductions in plasma angiotensinogen levels and clinically ...

The KARDINAL Phase 2 Randomized Clinical Trial

Among adults with uncontrolled hypertension, tonlamarsen 90 mg administered every 4 weeks for 20 weeks decreased plasma AGT by 67% from baseline compared with ...

Kardigan Announces Positive Phase 2 Data for ...

Results support initiation of Phase 2b clinical trial of tonlamarsen in patients with acute severe hypertension. Download Press Release PDF.

KARDINAL: Tonlamarsen Reduces Plasma AGT

A monthly dose of the novel drug tonlamarsen significantly reduced plasma angiotensinogen (AGT) levels in patients with uncontrolled ...