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
NCT ID: NCT06150924
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2023-12-14
2025-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Cohort 1
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
Cohort 2
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. At Screening, eGFRs of ≥30 mL/min/1.73 m2
3. At Screening, AOBP SBP of 135-180 mmHg, inclusive
4. On a stable treatment with an ACEi or ARB for at least 2 months prior to Screening
5. At Screening, body mass index (BMI) of \>18 kg/m2
Exclusion Criteria
2. Subjects with known hypersensitivity to dapagliflozin or any of its respective excipients (subjects beginning dapagliflozin only)
3. At Screening, serum potassium \>5.0 mmol/L
4. History of clinically significant hyponatremia within 1 year prior to Screening
5. Use of epithelial sodium channel (ENaC) inhibitors or Mineralocorticoid receptor antagonist (MRAs), including, but not limited to amiloride, triamterene, spironolactone, eplerenone, finerenone, from 4 weeks prior to the Screening Visit and during study participation. With the exception of MRAs in primary aldosteronism
6. Medical history of kidney disease related to autoimmune diseases (lupus, anti-neutrophil cytoplasmic antibody \[ANCA\] vasculitis), multiple myeloma or other known paraproteins, infiltrative diseases of the kidney, obstructive nephropathy, cystic kidney diseases, and renal transplantation
7. Medical history of advanced liver disease, including cirrhosis
8. Medical history of active autoimmune disease or recent (within 30 days) or anticipated need for immunosuppressive therapy
9. Diabetes mellitus with a glycosylated hemoglobin (HbA1c) \>10% (\>86 mmol/mol) at Screening
18 Years
ALL
No
Sponsors
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Mineralys Therapeutics Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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MLS-101-206
Identifier Type: -
Identifier Source: org_study_id
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