Study of JK07 in Patients With Chronic Heart Failure

Study acronym: RENEU-HF
StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Primary and study completion dates pushed to Oct 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 62 of 62 sites
    v9
  2. Study sites: 55 to 62v8
  3. Study sites: 42 to 55v7
  4. Study sites: 40 to 42
    • Eligibility criteria expanded, about 3 words
    v6
  5. Study sites: 22 to 40v5
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  1. Study sites: 6 to 22v4
  2. Re-verified, no change to tracked fieldsv3
  3. Primary endpoints revised (3)
    • Eligibility criteria expanded, about 28 words
    • Study title revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure. There will be 2 cohorts in this study: Cohort 1: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) of ≤ 40%. Cohort 2: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) \> 40% and ≤ 65%.
Trial Details
NCT Number NCT06369298
Lead Sponsor Salubris Biotherapeutics Inc
Conditions
(from sponsor)		 Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction
Related terms Atrial Fibrillation, Atrial Flutter, Fibromatosis, Gingival, 2, Heart Failure, Heart Failure, Diastolic, Heart Failure, Systolic
Enrollment 282 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov