Study to Assess the Effects of ALN-ANG3 in Adult Participants With Diabetic Kidney Disease
Recruiting · NCT07271186 · Interventional (participants receive a specific treatment) · Lead sponsor: Regeneron Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
ALN-ANG3EvinacumabPlacebo
What this trial is about
This study is researching an experimental drug called ALN-ANG3 (called "study drug"). 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
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Medical history of type 2 diabetes and receiving medical therapy or lifestyle interventions for glucose management
- Hemoglobin A1C (HbA1c) of 6.5 to 10% at screening
- 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
- Albuminuria: Urine Albumin to Creatinine Ratio (UACR) of 500 to 5000 mg/g at screening
- Key
Exclusion criteria
- Known medical history or clinical evidence indicative of non-diabetic renal disease
- Renal disease that required treatment with systemic immunosuppressive therapy (prior or current), or a history of end-stage kidney disease requiring treatment with chronic dialysis or kidney transplantation
- Medically unstable as assessed by the investigator or hospitalization (ie, \>24 hours) within 30 days of the screening visit
- NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Where it is running
58 locations listed across 17 US states.
- Apogee Clinical Research, LLC - Huntsville, Alabama, United States
- Applied Research Center of Arkansas - Little Rock, Arkansas, United States
- AME Clinical Research - Huntington Beach, California, United States
- Amicis Research Center - Northridge, California, United States
- FOMAT - Vista del Mar Medical Group - Oxnard, California, United States
- Central Coast Nephrology - Salinas, California, United States
- North America Research Institute - San Dimas, California, United States
- Amicis Research Center - Santa Clarita, California, United States
- Valiance Clinical Research - Tarzana, California, United States
- Amicis Research Center - Valencia, California, United States
- National Institute of Clinical Research, Inc. - Victorville, California, United States
- Yale University - New Haven, Connecticut, United States
- D&H Doral Research Center - Doral, Florida, United States
- AGA Clinical Trials - Hialeah, Florida, United States
- Convenient Medical Center - Hialeah, Florida, United States
- Elixia Hollywood - Hollywood, Florida, United States
- D&H Pompano Research Center - Margate, Florida, United States
- LCC Medical Research Institute - Miami, Florida, United States
- D&H National Research Centers, Inc - Miami, Florida, United States
- Regenerate Primary Medical Research, LLC - Miami, Florida, United States
- Ocean Blue Medical Research Center - Internal Medicine - Miami Springs, Florida, United States
- Innovia Research Center - Miramar, Florida, United States
- Central Florida Kidney Specialists Oakwater - Orlando, Florida, United States
- Bolanos Clinical Research - Pembroke Pines, Florida, United States
- Progressive Medical Research - Port Orange, Florida, United States
- CDC Research Institute - Port Saint Lucie, Florida, United States
- D&H Tamarac Research Center - Tamarac, Florida, United States
- Metabolic Research Institute - West Palm Beach, Florida, United States
- Privia Medical Group of Georgia, LLC - Savannah, Georgia, United States
- Research by Design, LLC - Internal Medicine - Chicago, Illinois, United States
- IMA Clinical Research - Monroe, Louisiana, United States
- University of Michigan - Ann Arbor, Michigan, United States
- Elixia Michigan Kidney Consultants - Pontiac, Michigan, United States
- Elixia MNA - City of Saint Peters, Missouri, United States
- Clinical Research Consultants, LLC - Kansas City, Missouri, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- DaVita Clinical Research - Las Vegas, Nevada, United States
- Velocity Clinical Research - Binghamton, New York, United States
- CHEAR Center LLC - The Bronx, New York, United States
- Eastern Nephrology Associates - Greenville West - Greenville, North Carolina, United States
- Eastern Nephrology Associates - New Bern - New Bern, North Carolina, United States
- Brookview Hills Research Associates, LLC - Winston-Salem, North Carolina, United States
- Northeast Clinical Research Center - Bethlehem, Pennsylvania, United States
- Suburban Research Associates - West Chester, Pennsylvania, United States
- Southeast Renal Research Institute - Chattanooga, Tennessee, United States
- Arlington Nephrology, PLLC. - Arlington, Texas, United States
- M3 Wake Research Dallas - Internal Medicine - Dallas, Texas, United States
- Revival Research Institute, LLC - Dallas, Texas, United States
- Epic Medical Research LLC - DeSoto, Texas, United States
- El Paso Kidney Specialists-Davita Clinical Research - El Paso, Texas, United States
- Juno Research, LLC - Houston, Texas, United States
- Prolato Research LLC - Houston, Texas, United States
- Clinical Trial Network, LLC - Houston, Texas, United States
- Gulf Coast Clinical Research - Katy, Texas, United States
- R & H Clinical Research, Inc. - Katy, Texas, United States
- Sunbeam Clinical Research - McKinney, Texas, United States
- Clinical Advancement Center - San Antonio, Texas, United States
- University of Texas Health - San Antonio - San Antonio, Texas, United States