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JK07 for Heart Failure (RENEU-HF Trial)
Phase 2
Recruiting
Research Sponsored by Salubris Biotherapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study entry through week 52
Summary
This trial is testing a new medication called JK07 in people aged 18-85 who have heart failure. The study includes two groups based on how well their heart is pumping. Participants will receive either a low dose or high dose of JK07. The goal is to see if JK07 can improve heart function and help these patients feel better.
Who is the study for?
This trial is for adults aged 18-85 with heart failure. It's split into two groups: one with severely reduced pumping function (ejection fraction ≤ 40%) and another with moderately reduced or preserved function (>40% to ≤65%). Participants will be randomly given either a low or high dose of JK07, or a placebo.
What is being tested?
The study tests the safety and effectiveness of different doses of JK07 compared to a placebo in improving heart failure symptoms. It's double-blind, meaning neither the participants nor the researchers know who gets the real drug versus placebo during the trial.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with new heart failure treatments may include changes in blood pressure, kidney function issues, electrolyte imbalances, dizziness, gastrointestinal problems, and potential allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study entry through week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study entry through week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy - Cohort 1
Safety - Cohort 1
Safety - Cohort 2
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: JK07 low doseActive Control1 Intervention
JK07 administered by intravenous (IV) infusion
Group II: JK07 high doseActive Control1 Intervention
JK07 administered by intravenous (IV) infusion
Group III: PlaceboPlacebo Group1 Intervention
Placebo administered by intravenous (IV) infusion
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Heart Failure (HF) include ACE inhibitors, beta-blockers, diuretics, and investigational therapies like JK07. ACE inhibitors work by blocking the conversion of angiotensin I to angiotensin II, reducing blood pressure and decreasing the heart's workload.
Beta-blockers slow the heart rate and reduce blood pressure, improving heart function over time. Diuretics help remove excess fluid from the body, alleviating symptoms like swelling and shortness of breath.
Investigational therapies, such as JK07, aim to target specific pathways involved in HF to improve heart function and patient outcomes. These treatments are crucial for managing HF as they help to improve symptoms, enhance quality of life, and reduce the risk of hospitalization and mortality.
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Who is running the clinical trial?
Salubris Biotherapeutics IncLead Sponsor
4 Previous Clinical Trials
432 Total Patients Enrolled
2 Trials studying Heart Failure
14 Patients Enrolled for Heart Failure