Phase
Condition
Renal Failure
Stress
Circulation Disorders
Treatment
Part A - Lorundrostat QD + Dapaglifozin QD
Placebo QD + SGLT2i QD, Washout, Lorundrostat 25mg+SGLT2i QD
Part B - Lorundrostat QD Open Label
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Major Inclusion Criteria:
At Screening, UACR of 200-5000 mg/g, inclusive, in first morning urine void
At Screening, eGFRs of ≥30 mL/min/1.73 m2
At Screening, AOBP SBP of 135-180 mmHg, inclusive
On a stable treatment with an ACEi or ARB for at least 2 months prior to Screening
At Screening, body mass index (BMI) of >18 kg/m2
Exclusion
Major Exclusion Criteria:
Subjects with known hypersensitivity to lorundrostat or any of its respectiveexcipients
Subjects with known hypersensitivity to dapagliflozin or any of its respectiveexcipients (subjects beginning dapagliflozin only)
At Screening, serum potassium >5.0 mmol/L
History of clinically significant hyponatremia within 1 year prior to Screening
Use of epithelial sodium channel (ENaC) inhibitors or Mineralocorticoid receptorantagonist (MRAs), including, but not limited to amiloride, triamterene,spironolactone, eplerenone, finerenone, from 4 weeks prior to the Screening Visitand during study participation. With the exception of MRAs in primary aldosteronism
Medical history of kidney disease related to autoimmune diseases (lupus,anti-neutrophil cytoplasmic antibody [ANCA] vasculitis), multiple myeloma or otherknown paraproteins, infiltrative diseases of the kidney, obstructive nephropathy,cystic kidney diseases, and renal transplantation
Medical history of advanced liver disease, including cirrhosis
Medical history of active autoimmune disease or recent (within 30 days) oranticipated need for immunosuppressive therapy
Diabetes mellitus with a glycosylated hemoglobin (HbA1c) >10% (>86 mmol/mol) atScreening
Study Design
Study Description
Connect with a study center
Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thunderbird Office
Glendale, Arizona 85306
United StatesSite Not Available
Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thomas Office
Phoenix, Arizona 85016
United StatesSite Not Available
Balboa Nephrology Medical Group, Inc. (BNMG) - California Institute of Renal Research (CIRR) - Chula Vista
Chula Vista, California 91910
United StatesSite Not Available
Balboa Nephrology Medical Group, Inc. (BNMG) - El Centro
El Centro, California 92243
United StatesSite Not Available
Amicis Research Center - Granada Hills
Granada Hills, California 91344
United StatesSite Not Available
Balboa Nephrology Medical Group, Inc. (Bnmg) - La Mesa
La Mesa, California 91942-3059
United StatesSite Not Available
Academic Medical Research Institute (AMRI) - Los Angeles
Los Angeles, California 90022
United StatesSite Not Available
Amicis Research Center
Northridge, California 91324
United StatesSite Not Available
Amicis Research Center - Vacaville
Vacaville, California 95687-3560
United StatesSite Not Available
Colorado Kidney Care (Denver Nephrology) - Denver Office
Denver, Colorado 80218-1216
United StatesSite Not Available
Qway Research
Coconut Grove, Florida 33133
United StatesSite Not Available
Indago Research and Health Center
Hialeah, Florida 33012
United StatesSite Not Available
Elixia Pines, LLC
Hollywood, Florida 33024
United StatesSite Not Available
Elixia Central Florida, LLC
Orlando, Florida 32806
United StatesSite Not Available
Infigo Clinical Research, Llc
Sanford, Florida 32771
United StatesSite Not Available
Genesis Clinical Research - Tampa
Tampa, Florida 33614
United StatesSite Not Available
Palm Beach Diabetes and Endocrine Specialists, PA (PBDES) - West Palm Beach Office
West Palm Beach, Florida 33401
United StatesSite Not Available
American Clinical Trials Llc
Acworth, Georgia 30101
United StatesSite Not Available
Nephrology of the Golden Isles - Brunswick
Brunswick, Georgia 31520
United StatesSite Not Available
ClinCept, LLC
Columbus, Georgia 32896
United StatesSite Not Available
Georgia Nephrology, Llc
Lawrenceville, Georgia 30046-8761
United StatesSite Not Available
Nephrology Associates of Kentuckiana, PSC (NAK)
Louisville, Kentucky 40205
United StatesSite Not Available
Lcms Health University Medical Center New Orleans
New Orleans, Louisiana 70112-3018
United StatesSite Not Available
Northwest Louisiana Nephrology, Llc - Shreveport
Shreveport, Louisiana 71101
United StatesSite Not Available
Tufts University School of Medicine (Tusm) - Tufts Medical Center (Tmc) (Tufts-New England Medical Center)
Boston, Massachusetts 02111
United StatesSite Not Available
Elixia MKC, LLC
Pontiac, Michigan 48341
United StatesSite Not Available
Kansas City Kidney Consultants (Arms, Dodge, Robinson, Wilber & Crouch, Inc.) - Kansas City
Kansas City, Missouri 64111
United StatesSite Not Available
Seacoast Kidney & Hypertension Specialists - Portsmouth Office
Portsmouth, New Hampshire 03801
United StatesSite Not Available
Suny Downstate Medical Center - Parkside Dialysis Center
Brooklyn, New York 11226-1508
United StatesSite Not Available
Nephrology Associates
Fresh Meadows, New York 11365
United StatesSite Not Available
Nephrology Associates, PC
Fresh Meadows, New York 11365
United StatesSite Not Available
Triad Internal Medicine
Asheboro, North Carolina 27205
United StatesSite Not Available
Nephrology Associates, Pllc - Winston-Salem
Winston Salem, North Carolina 27103
United StatesSite Not Available
Nephrology Associates, Pllc - Winston-Salem
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Nephrology Consultants - Oklahoma City
Oklahoma City, Oklahoma 73116-1516
United StatesSite Not Available
Columbia Nephrology
Columbia, South Carolina 29203
United StatesSite Not Available
Southeast Renal Research Institute
Chattanooga, Tennessee 37408
United StatesSite Not Available
Dallas Nephrology Associates (Dna) - Renal Disease Research Institute (Rdri)
Dallas, Texas 75235
United StatesSite Not Available
Liberty Research Center
Dallas, Texas 75237
United StatesSite Not Available
R&H Clinical Research
Katy, Texas 27205
United StatesSite Not Available
E T Nephrology Associates - Lufkin
Lufkin, Texas 75904
United StatesSite Not Available
Prx Research
Mesquite, Texas 75149
United StatesSite Not Available
Gamma Medical Research, Inc
Mission, Texas 78572
United StatesSite Not Available
Chrysalis Clinical Research (CCR)
Saint George, Utah 84790
United StatesSite Not Available
Mendez Center for Clinical Research, LLC
Woodbridge, Virginia 22191
United StatesSite Not Available
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