A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of JK07 in Adults With Chronic Heart Failure (RENEU-HF)

Status: Recruiting
Location: See all (62) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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%.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Participants with New York Heart Association (NYHA) Class II-III.

• Cohort 1 - Left Ventricular Ejection Fraction (LVEF) ≤ 40%.

• Cohort 2 - Left Ventricular Ejection Fraction (LVEF) \>40% and ≤ 65%, elevated N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥ 600pg/mL and atrial fibrillation/flutter.

• Stable heart failure and on optimal medical therapy.

• Screening hemoglobin ≥ 9.0 g/dL.

Locations
United States
Alabama
Site 121
RECRUITING
Alexander City
Site 130
RECRUITING
Birmingham
Site 139
RECRUITING
Birmingham
Site 138
RECRUITING
Huntsville
Arkansas
Site 127
RECRUITING
Little Rock
Arizona
Site 111
RECRUITING
Phoenix
California
Site 128
RECRUITING
Huntington Beach
Site 157
RECRUITING
Los Angeles
Site 158
RECRUITING
Orange
Site 116
RECRUITING
Pasadena
Site 129
RECRUITING
Santa Maria
Site 102
RECRUITING
Stanford
Site 113
RECRUITING
Torrance
Site 133
RECRUITING
Vista
Florida
Site 161
RECRUITING
Coral Gables
Site 114
RECRUITING
Hialeah
Site 162
RECRUITING
Miami Lakes
Site 159
RECRUITING
Naples
Georgia
Site 136
RECRUITING
Atlanta
Idaho
Site 143
RECRUITING
Boise
Illinois
Site 160
RECRUITING
Chicago
Site 154
RECRUITING
Park Ridge
Indiana
Site 137
RECRUITING
Fort Wayne
Site 112
RECRUITING
Indianapolis
Louisiana
Site 104
RECRUITING
Covington
Massachusetts
Site 119
RECRUITING
Boston
Maryland
Site 118
RECRUITING
Baltimore
Michigan
Site 122
RECRUITING
Bloomfield Hills
Site 150
RECRUITING
Farmington Hills
Minnesota
Site 107
RECRUITING
Rochester
Missouri
Site 105
RECRUITING
St Louis
Site 106
RECRUITING
St Louis
North Carolina
Site 152
RECRUITING
Asheville
Site 109
RECRUITING
Cary
Site 140
RECRUITING
Charlotte
Site 145
RECRUITING
Durham
New Jersey
Site 144
RECRUITING
Brick
New York
Site 153
RECRUITING
Valhalla
Ohio
Site 117
RECRUITING
Cincinnati
Site 100
RECRUITING
Cleveland
Oklahoma
Site 135
RECRUITING
Oklahoma City
Oregon
Site 101
RECRUITING
Portland
Pennsylvania
Site 155
RECRUITING
York
Texas
Site 110
RECRUITING
Dallas
Site 115
RECRUITING
Dallas
Site 103
RECRUITING
Houston
Site 149
RECRUITING
Tomball
Virginia
Site 148
RECRUITING
Arlington
Site 123
RECRUITING
Falls Church
Site 126
RECRUITING
Norfolk
Site 163
RECRUITING
Vienna
Other Locations
Canada
Site 203
RECRUITING
Brampton
Site 200
RECRUITING
Chicoutimi
Site 201
RECRUITING
Trois-rivières
Site 202
RECRUITING
Winnepeg
China
Site 300
RECRUITING
Beijing
Site 305
RECRUITING
Changsha
Site 301
RECRUITING
Chengdu
Site 304
RECRUITING
Chongqing
Site 306
RECRUITING
Jining
Site 303
RECRUITING
Nanjing
Puerto Rico
Site 156
RECRUITING
Ponce
Contact Information
Primary
Amanda McEwen
Info@SalubrisBio.com
888-521-8961
Backup
Ashleigh Chasteen
Info@Salubrisbio.com
888-521-8961
Time Frame
Start Date: 2024-03-28
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 282
Treatments
Active_comparator: JK07 low dose
JK07 administered by intravenous (IV) infusion
Active_comparator: JK07 high dose
JK07 administered by intravenous (IV) infusion
Placebo_comparator: Placebo
Placebo administered by intravenous (IV) infusion
Sponsors
Leads: Salubris Biotherapeutics Inc

This content was sourced from clinicaltrials.gov