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Efficacy and Safety of Lorundrostat in Addition to Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i) in Subjects With Hypertension and Chronic Kidney Disease (CKD) With Albuminuria
Sponsor: Mineralys Therapeutics Inc.
Summary
This is a randomized, double-blind (DB), placebo controlled, crossover study with a two-period, two-sequence (2x2) design evaluating the efficacy and safety of 25 mg QD lorundrostat (an aldosterone synthase inhibitor \[ASI\]) in addition to a SGLT2i for the treatment of hypertension in subjects with CKD and albuminuria while receiving stable treatment with an Angiotensin-converting enzyme inhibitor (ACEi) or an Angiotensin receptor blocker (ARB). Subjects will be at least 18 years old with hypertension, and mild to severe CKD with albuminuria at the Screening Visit.
Official title: A Randomized, Crossover, Double Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Lorundrostat in Addition to Sodium-Glucose Cotransporter-2 Inhibitors, in Adults With Hypertension and Chronic Kidney Disease With Albuminuria
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-12-14
Completion Date
2025-04-23
Last Updated
2026-06-03
Healthy Volunteers
No
Conditions
Interventions
Lorundrostat 25mg+SGLT2i QD, Washout, Placebo+SGLT2i QD
Period 1 - Lorundrostat 25mg QD + SGLT2i QD 4 weeks; Washout - Placebo QD + SGLT2i QD 4 weeks; Period 2 - Placebo QD + SGLT2i QD 4 weeks
Placebo QD + SGLT2i QD, Washout, Lorundrostat 25mg+SGLT2i QD
Period 1 - Placebo QD + SGLT2i QD 4 weeks; Washout - Placebo QD + SGLT2i QD 4 weeks; Period 2 - Lorundrostat 25mg + SGLT2i QD 4 weeks
Locations (44)
Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thunderbird Office
Glendale, Arizona, United States
Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thomas Office
Phoenix, Arizona, United States
Balboa Nephrology Medical Group, Inc. (BNMG) - California Institute of Renal Research (CIRR) - Chula Vista
Chula Vista, California, United States
Balboa Nephrology Medical Group, Inc. (BNMG) - El Centro
El Centro, California, United States
Amicis Research Center - Granada Hills
Granada Hills, California, United States
Balboa Nephrology Medical Group, Inc. (Bnmg) - La Mesa
La Mesa, California, United States
Academic Medical Research Institute (AMRI) - Los Angeles
Los Angeles, California, United States
Amicis Research Center
Northridge, California, United States
Amicis Research Center - Vacaville
Vacaville, California, United States
Colorado Kidney Care (Denver Nephrology) - Denver Office
Denver, Colorado, United States
Qway Research
Coconut Grove, Florida, United States
Indago Research and Health Center
Hialeah, Florida, United States
Elixia Pines, LLC
Hollywood, Florida, United States
Elixia Central Florida, LLC
Orlando, Florida, United States
Infigo Clinical Research, Llc
Sanford, Florida, United States
Genesis Clinical Research - Tampa
Tampa, Florida, United States
Palm Beach Diabetes and Endocrine Specialists, PA (PBDES) - West Palm Beach Office
West Palm Beach, Florida, United States
American Clinical Trials Llc
Acworth, Georgia, United States
Nephrology of the Golden Isles - Brunswick
Brunswick, Georgia, United States
ClinCept, LLC
Columbus, Georgia, United States
Georgia Nephrology, Llc
Lawrenceville, Georgia, United States
Nephrology Associates of Kentuckiana, PSC (NAK)
Louisville, Kentucky, United States
Lcms Health University Medical Center New Orleans
New Orleans, Louisiana, United States
Northwest Louisiana Nephrology, Llc - Shreveport
Shreveport, Louisiana, United States
Tufts University School of Medicine (Tusm) - Tufts Medical Center (Tmc) (Tufts-New England Medical Center)
Boston, Massachusetts, United States
Elixia MKC, LLC
Pontiac, Michigan, United States
Kansas City Kidney Consultants (Arms, Dodge, Robinson, Wilber & Crouch, Inc.) - Kansas City
Kansas City, Missouri, United States
Seacoast Kidney & Hypertension Specialists - Portsmouth Office
Portsmouth, New Hampshire, United States
Suny Downstate Medical Center - Parkside Dialysis Center
Brooklyn, New York, United States
Nephrology Associates, PC
Fresh Meadows, New York, United States
Nephrology Associates
Fresh Meadows, New York, United States
Triad Internal Medicine
Asheboro, North Carolina, United States
Nephrology Associates, Pllc - Winston-Salem
Winston-Salem, North Carolina, United States
Nephrology Consultants - Oklahoma City
Oklahoma City, Oklahoma, United States
Columbia Nephrology
Columbia, South Carolina, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
Dallas Nephrology Associates (Dna) - Renal Disease Research Institute (Rdri)
Dallas, Texas, United States
Liberty Research Center
Dallas, Texas, United States
R&H Clinical Research
Katy, Texas, United States
E T Nephrology Associates - Lufkin
Lufkin, Texas, United States
Prx Research
Mesquite, Texas, United States
Gamma Medical Research, Inc
Mission, Texas, United States
Chrysalis Clinical Research (CCR)
St. George, Utah, United States
Mendez Center for Clinical Research, LLC
Woodbridge, Virginia, United States