Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease
Purpose
This study is researching experimental drugs called ALN-ANG3 and evinacumab (called "study drugs"). The study is focused on participants who have diabetic kidney disease. The aim of the study is to see how safe and effective the study drugs are. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in the blood at different times
Condition
- Diabetic Kidney Disease (DKD)
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Medical history of type 2 diabetes and receiving medical therapy or lifestyle interventions for glucose management 2. Hemoglobin A1C (HbA1c) of 6.5 to 10% at screening 3. eGFR 30 to 90 mL/min/1.73 m^2 using 2021 Chronic Kidney Disease-Epidemiology Collaboration-Estimated Glomerular Filtration Rate using Creatinine and Cystatin C (CKD-EPI eGFRcr-cys) equation at screening 4. Albuminuria: Urine Albumin to Creatinine Ratio (UACR) of 500 to 5000 mg/g at screening
Exclusion Criteria
- Known medical history or clinical evidence indicative of non-diabetic renal disease 2. Renal disease that required treatment with systemic immunosuppressive therapy, or a history of dialysis or renal transplant 3. Medically unstable as assessed by the investigator 4. Hospitalization (ie, >24 hours) within 30 days of the screening visit NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ALN-ANG3 + evinacumab placebo |
|
|
|
Experimental ALN-ANG3 + evinacumab |
|
|
|
Placebo Comparator ALN-ANG3 placebo + evinacumab placebo |
|
Recruiting Locations
Apogee Clinical Research, LLC
Huntsville, Alabama 35801
Huntsville, Alabama 35801
Applied Research Center of Arkansas
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
AME Clinical Research
Huntington Beach, California 92647
Huntington Beach, California 92647
Amicis Research Center
Northridge, California 91325
Northridge, California 91325
FOMAT - Vista del Mar Medical Group
Oxnard, California 93036
Oxnard, California 93036
Central Coast Nephrology
Salinas, California 93901
Salinas, California 93901
North America Research Institute
San Dimas, California 91773
San Dimas, California 91773
Amicis Research Center
Santa Clarita, California 91355
Santa Clarita, California 91355
Valiance Clinical Research
Tarzana, California 91356
Tarzana, California 91356
Amicis Research Center
Valencia, California 91355
Valencia, California 91355
National Institute of Clinical Research, Inc.
Victorville, California 92392
Victorville, California 92392
D&H Doral Research Center
Doral, Florida 33122
Doral, Florida 33122
AGA Clinical Trials
Hialeah, Florida 33012
Hialeah, Florida 33012
Convenient Medical Center
Hialeah, Florida 33013
Hialeah, Florida 33013
Elixia Hollywood
Hollywood, Florida 33024
Hollywood, Florida 33024
D&H Pompano Research Center
Margate, Florida 33063
Margate, Florida 33063
LCC Medical Research Institute
Miami, Florida 33126
Miami, Florida 33126
D&H National Research Centers, Inc
Miami, Florida 33155
Miami, Florida 33155
Regenerate Primary Medical Research, LLC
Miami, Florida 33155
Miami, Florida 33155
Ocean Blue Medical Research Center - Internal Medicine
Miami Springs, Florida 33166
Miami Springs, Florida 33166
Innovia Research Center
Miramar, Florida 33027
Miramar, Florida 33027
Bolanos Clinical Research
Pembroke Pines, Florida 33026
Pembroke Pines, Florida 33026
Progressive Medical Research
Port Orange, Florida 32127
Port Orange, Florida 32127
CDC Research Institute
Port Saint Lucie, Florida 34952
Port Saint Lucie, Florida 34952
D&H Tamarac Research Center
Tamarac, Florida 33321
Tamarac, Florida 33321
Metabolic Research Institute
West Palm Beach, Florida 33401
West Palm Beach, Florida 33401
Privia Medical Group of Georgia, LLC
Savannah, Georgia 31406
Savannah, Georgia 31406
Research by Design, LLC - Internal Medicine
Chicago, Illinois 60643
Chicago, Illinois 60643
Elixia Michigan Kidney Consultants
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Elixia MNA
City of Saint Peters, Missouri 63376
City of Saint Peters, Missouri 63376
Clinical Research Consultants, LLC
Kansas City, Missouri 64111
Kansas City, Missouri 64111
DaVita Clinical Research
Las Vegas, Nevada 89107
Las Vegas, Nevada 89107
Velocity Clinical Research
Binghamton, New York 13905
Binghamton, New York 13905
CHEAR Center LLC
The Bronx, New York 10455
The Bronx, New York 10455
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
Northeast Clinical Research Center
Bethlehem, Pennsylvania 18017
Bethlehem, Pennsylvania 18017
Suburban Research Associates
West Chester, Pennsylvania 19380
West Chester, Pennsylvania 19380
Southeast Renal Research Institute
Chattanooga, Tennessee 37404
Chattanooga, Tennessee 37404
Arlington Nephrology, PLLC.
Arlington, Texas 76015
Arlington, Texas 76015
M3 Wake Research Dallas - Internal Medicine
Dallas, Texas 75224
Dallas, Texas 75224
El Paso Kidney Specialists-Davita Clinical Research
El Paso, Texas 79902
El Paso, Texas 79902
Juno Research, LLC
Houston, Texas 77040
Houston, Texas 77040
Clinical Trial Network, LLC
Houston, Texas 77074
Houston, Texas 77074
Gulf Coast Clinical Research
Katy, Texas 77450
Katy, Texas 77450
R & H Clinical Research, Inc.
Katy, Texas 77450
Katy, Texas 77450
Sunbeam Clinical Research
McKinney, Texas 75069
McKinney, Texas 75069
Clinical Advancement Center
San Antonio, Texas 78212
San Antonio, Texas 78212
More Details
- Status
- Recruiting
- Sponsor
- Regeneron Pharmaceuticals