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Clinical Trial Details

Trial ID: L0158
Source ID: NCT06150924
Associated Drug: Lorundrostat 25mg+Sglt2i Qd, Washout, Placebo+Sglt2i Qd
Title: 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
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: Lorundrostat 25mg+SGLT2i QD, Washout, Placebo+SGLT2i QD|DRUG: Placebo QD + SGLT2i QD, Washout, Lorundrostat 25mg+SGLT2i QD
Outcome Measures: Primary: Placebo-adjusted change from baseline in automated office blood pressure (AOBP) systolic blood pressure (SBP) at Week 4, baseline to Week 4|Incidence and severity of adverse events (AEs), baseline to Week 14 | Other: Placebo-adjusted percent change from baseline in 24-hour urine albumin at Study Week 4, baseline to Study Week 4|Placebo-adjusted change from baseline in AOBP diastolic blood pressure (DBP) at Study Week 4, Study Week 4|Change from baseline in AOBP SBP at Study Week 4 lorundrostat treatment periods, Study Week 4|Percent change from baseline in 24-hour urine albumin at Study Week 4 in lorundrostat treatment periods, baseline to Study Week 4|Placebo-adjusted percent change from baseline in 24-hour urine protein Study Week 4, baseline to Study Week 4|Placebo-adjusted percent change from baseline in urine albumin to creatinine ratio (UACR) at Study Week 4, baseline to Study Week 4|Change in biomarkers from baseline to Study Week 4 in lorundrostat treatment periods, baseline to Study Week 4|Placebo-adjusted percent change in estimated glomerular filtration rate (eGFR) from baseline to Study Week 4, baseline to Study Week 4|Percent change in eGFR from Study Week 4 to Study Week 8, Study Week 4 to Study Week 8
Sponsor/Collaborators: Sponsor: Mineralys Therapeutics Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2023-12-14
Completion Date: 2025-05
Results First Posted:
Last Update Posted: 2025-02-21
Locations: Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thunderbird Office, Glendale, Arizona, 85306, United States|Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thomas Office, Phoenix, Arizona, 85016, United States|Balboa Nephrology Medical Group, Inc. (BNMG) - California Institute of Renal Research (CIRR) - Chula Vista, Chula Vista, California, 91910, United States|Balboa Nephrology Medical Group, Inc. (BNMG) - El Centro, El Centro, California, 92243, United States|Amicis Research Center - Granada Hills, Granada Hills, California, 91344, United States|Balboa Nephrology Medical Group, Inc. (Bnmg) - La Mesa, La Mesa, California, 91942-3059, United States|Academic Medical Research Institute (AMRI) - Los Angeles, Los Angeles, California, 90022, United States|Amicis Research Center, Northridge, California, 91324, United States|Amicis Research Center - Vacaville, Vacaville, California, 95687-3560, United States|Colorado Kidney Care (Denver Nephrology) - Denver Office, Denver, Colorado, 80218-1216, United States|Qway Research, Coconut Grove, Florida, 33133, United States|Indago Research and Health Center, Hialeah, Florida, 33012, United States|Elixia Pines, LLC, Hollywood, Florida, 33024, United States|Elixia Central Florida, LLC, Orlando, Florida, 32806, United States|Infigo Clinical Research, Llc, Sanford, Florida, 32771, United States|Genesis Clinical Research - Tampa, Tampa, Florida, 33614, United States|Palm Beach Diabetes and Endocrine Specialists, PA (PBDES) - West Palm Beach Office, West Palm Beach, Florida, 33401, United States|American Clinical Trials Llc, Acworth, Georgia, 30101, United States|Nephrology of the Golden Isles - Brunswick, Brunswick, Georgia, 31520, United States|ClinCept, LLC, Columbus, Georgia, 32896, United States|Georgia Nephrology, Llc, Lawrenceville, Georgia, 30046-8761, United States|Nephrology Associates of Kentuckiana, PSC (NAK), Louisville, Kentucky, 40205, United States|Lcms Health University Medical Center New Orleans, New Orleans, Louisiana, 70112-3018, United States|Northwest Louisiana Nephrology, Llc - Shreveport, Shreveport, Louisiana, 71101, United States|Tufts University School of Medicine (Tusm) - Tufts Medical Center (Tmc) (Tufts-New England Medical Center), Boston, Massachusetts, 02111, United States|Elixia MKC, LLC, Pontiac, Michigan, 48341, United States|Kansas City Kidney Consultants (Arms, Dodge, Robinson, Wilber & Crouch, Inc.) - Kansas City, Kansas City, Missouri, 64111, United States|Seacoast Kidney & Hypertension Specialists - Portsmouth Office, Portsmouth, New Hampshire, 03801, United States|Suny Downstate Medical Center - Parkside Dialysis Center, Brooklyn, New York, 11226-1508, United States|Nephrology Associates, PC, Fresh Meadows, New York, 11365, United States|Nephrology Associates, Fresh Meadows, New York, 11365, United States|Triad Internal Medicine, Asheboro, North Carolina, 27205, United States|Nephrology Associates, Pllc - Winston-Salem, Winston Salem, North Carolina, 27103, United States|Nephrology Consultants - Oklahoma City, Oklahoma City, Oklahoma, 73116-1516, United States|Columbia Nephrology, Columbia, South Carolina, 29203, United States|Southeast Renal Research Institute, Chattanooga, Tennessee, 37408, United States|Dallas Nephrology Associates (Dna) - Renal Disease Research Institute (Rdri), Dallas, Texas, 75235, United States|Liberty Research Center, Dallas, Texas, 75237, United States|R&H Clinical Research, Katy, Texas, 27205, United States|E T Nephrology Associates - Lufkin, Lufkin, Texas, 75904, United States|Prx Research, Mesquite, Texas, 75149, United States|Gamma Medical Research, Inc, Mission, Texas, 78572, United States|Chrysalis Clinical Research (CCR), Saint George, Utah, 84790, United States|Mendez Center for Clinical Research, LLC, Woodbridge, Virginia, 22191, United States
URL: https://clinicaltrials.gov/show/NCT06150924

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress