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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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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

  1. 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

ArmDescriptionAssigned Intervention
Experimental
ALN-ANG3 + evinacumab placebo
  • Drug: ALN-ANG3
    Administered per the protocol
  • Drug: Evinacumab placebo
    Administered per the protocol
Experimental
ALN-ANG3 + evinacumab
  • Drug: ALN-ANG3
    Administered per the protocol
  • Drug: Evinacumab
    Administered per the protocol
    Other names:
    • Evkeeza®
    • R1500
Placebo Comparator
ALN-ANG3 placebo + evinacumab placebo
  • Drug: ALN-ANG3 placebo
    Administered per the protocol
  • Drug: Evinacumab placebo
    Administered per the protocol

Recruiting Locations

Apogee Clinical Research, LLC
Huntsville, Alabama 35801

Applied Research Center of Arkansas
Little Rock, Arkansas 72205

AME Clinical Research
Huntington Beach, California 92647

Amicis Research Center
Northridge, California 91325

FOMAT - Vista del Mar Medical Group
Oxnard, California 93036

Central Coast Nephrology
Salinas, California 93901

North America Research Institute
San Dimas, California 91773

Amicis Research Center
Santa Clarita, California 91355

Valiance Clinical Research
Tarzana, California 91356

Amicis Research Center
Valencia, California 91355

National Institute of Clinical Research, Inc.
Victorville, California 92392

D&H Doral Research Center
Doral, Florida 33122

AGA Clinical Trials
Hialeah, Florida 33012

Convenient Medical Center
Hialeah, Florida 33013

Elixia Hollywood
Hollywood, Florida 33024

D&H Pompano Research Center
Margate, Florida 33063

LCC Medical Research Institute
Miami, Florida 33126

D&H National Research Centers, Inc
Miami, Florida 33155

Regenerate Primary Medical Research, LLC
Miami, Florida 33155

Ocean Blue Medical Research Center - Internal Medicine
Miami Springs, Florida 33166

Innovia Research Center
Miramar, Florida 33027

Bolanos Clinical Research
Pembroke Pines, Florida 33026

Progressive Medical Research
Port Orange, Florida 32127

CDC Research Institute
Port Saint Lucie, Florida 34952

D&H Tamarac Research Center
Tamarac, Florida 33321

Metabolic Research Institute
West Palm Beach, Florida 33401

Privia Medical Group of Georgia, LLC
Savannah, Georgia 31406

Research by Design, LLC - Internal Medicine
Chicago, Illinois 60643

Elixia Michigan Kidney Consultants
Pontiac, Michigan 48341

Elixia MNA
City of Saint Peters, Missouri 63376

Clinical Research Consultants, LLC
Kansas City, Missouri 64111

DaVita Clinical Research
Las Vegas, Nevada 89107

Velocity Clinical Research
Binghamton, New York 13905

CHEAR Center LLC
The Bronx, New York 10455

Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina 27103

Northeast Clinical Research Center
Bethlehem, Pennsylvania 18017

Suburban Research Associates
West Chester, Pennsylvania 19380

Southeast Renal Research Institute
Chattanooga, Tennessee 37404

Arlington Nephrology, PLLC.
Arlington, Texas 76015

M3 Wake Research Dallas - Internal Medicine
Dallas, Texas 75224

El Paso Kidney Specialists-Davita Clinical Research
El Paso, Texas 79902

Juno Research, LLC
Houston, Texas 77040

Clinical Trial Network, LLC
Houston, Texas 77074

Gulf Coast Clinical Research
Katy, Texas 77450

R & H Clinical Research, Inc.
Katy, Texas 77450

Sunbeam Clinical Research
McKinney, Texas 75069

Clinical Advancement Center
San Antonio, Texas 78212

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.