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JK07 low dose 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

Awards & highlights

RENEU-HF Trial Summary

"This trial is testing a new drug, JK07, on adults aged 18-85 with heart failure. The study will have two groups of participants based on the strength of their heart. Participants will

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.Check my eligibility

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.See study design

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.

RENEU-HF Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and study entry through week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy - Cohort 1

Safety - Cohort 1

Safety - Cohort 2

RENEU-HF 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Salubris Biotherapeutics IncLead Sponsor

3 Previous Clinical Trials

277 Total Patients Enrolled

2 Trials studying Heart Failure

14 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study allow participation for individuals older than 20 years of age?

"The trial is seeking individuals aged above 18 and below 85 years."

Answered by AI

Has the FDA given its approval for the use of JK07 in low doses?

"The safety evaluation by Power team for JK07 low dose in this Phase 2 trial is rated at 2, indicating some existing safety data but no efficacy evidence."

Answered by AI

In how many medical facilities is this examination being conducted?

"Six medical facilities, such as New Generation of Medical Research in Hialeah and Louisiana Heart Center in Covington, are currently conducting this trial. Additional sites include St. Louis Heart and Vascular Cardiology in Saint Louis among others."

Answered by AI

How large is the patient population participating in this medical study?

"A total of 282 eligible individuals are required to meet the inclusion criteria and partake in this medical investigation. Prospective participants have the option to engage in this research at various sites, including New Generation of Medical Research situated in Hialeah, Florida, as well as Louisiana Heart Center located in Covington, Louisiana."

Answered by AI

Are eligible patients able to enroll in this ongoing trial at the present time?

"Indeed, as per clinicaltrials.gov, this current research endeavor is actively seeking eligible participants. The study was initially shared on March 28th, 2024 and the most recent update occurred on April 12th of the same year. A total of 282 individuals are sought for enrollment across six distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of JK07 in Patients With Chronic Heart Failure

2024. "Study of JK07 in Patients With Chronic Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06369298.

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