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
Completed · Phase 2 · Has a placebo group
Conditions studied: Chronic Kidney Disease
In brief
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.
Key facts
- Study ID
- NCT06150924
- Run by
- Mineralys Therapeutics Inc.
- People needed
- 60
- Starts
- 2023-12-14
- Expected to finish
- 2025-04-23
- Last updated by the study team
- 2026-06-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mendez Center for Clinical Research, LLC — Woodbridge, Virginia, United States
- 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
Full record on ClinicalTrials.gov
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