New pill shows promise for Tough-to-Treat blood pressure in kidney patients
NCT ID NCT06150924
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tested whether adding the experimental drug lorundrostat to standard SGLT2 inhibitor therapy can lower blood pressure in adults with chronic kidney disease and albuminuria (protein in urine). Sixty participants received either lorundrostat or a placebo for four weeks, then switched. The study is complete, and results will show if the drug safely improves blood pressure control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lorundrostat (an aldosterone synthase inhibitor) taken as a pill once daily
- What this could lead to
- If successful, this could point toward a new add-on treatment to better control blood pressure and protect kidney function in people with chronic kidney disease.
- What could go wrong
- This is a small, early-phase trial with only 60 participants and short treatment periods. Results may not apply to everyone, and the drug may cause side effects or fail to show clear benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
60 people
The number who actually took part.
- Started
-
Dec 2023
- Finished
-
Apr 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Major Inclusion Criteria: 1. At Screening, UACR of 200-5000 mg/g, inclusive, in first morning urine void 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 Major Exclusion Criteria: 1. Subjects with known hypersensitivity to lorundrostat or any of its respective excipients 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Academic Medical Research Institute (AMRI) - Los Angeles
Los Angeles, California, 90022, United States
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American Clinical Trials Llc
Acworth, Georgia, 30101, United States
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Amicis Research Center
Northridge, California, 91324, United States
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Amicis Research Center - Granada Hills
Granada Hills, California, 91344, United States
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Amicis Research Center - Vacaville
Vacaville, California, 95687-3560, United States
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Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thomas Office
Phoenix, Arizona, 85016, United States
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Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thunderbird Office
Glendale, Arizona, 85306, United States
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Balboa Nephrology Medical Group, Inc. (BNMG) - California Institute of Renal Research (CIRR) - Chula Vista
Chula Vista, California, 91910, United States
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Balboa Nephrology Medical Group, Inc. (BNMG) - El Centro
El Centro, California, 92243, United States
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Balboa Nephrology Medical Group, Inc. (Bnmg) - La Mesa
La Mesa, California, 91942-3059, United States
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Chrysalis Clinical Research (CCR)
St. George, Utah, 84790, United States
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ClinCept, LLC
Columbus, Georgia, 32896, United States
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Colorado Kidney Care (Denver Nephrology) - Denver Office
Denver, Colorado, 80218-1216, United States
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Columbia Nephrology
Columbia, South Carolina, 29203, United States
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Dallas Nephrology Associates (Dna) - Renal Disease Research Institute (Rdri)
Dallas, Texas, 75235, United States
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E T Nephrology Associates - Lufkin
Lufkin, Texas, 75904, United States
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Elixia Central Florida, LLC
Orlando, Florida, 32806, United States
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Elixia MKC, LLC
Pontiac, Michigan, 48341, United States
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Elixia Pines, LLC
Hollywood, Florida, 33024, United States
-
Gamma Medical Research, Inc
Mission, Texas, 78572, United States
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Genesis Clinical Research - Tampa
Tampa, Florida, 33614, United States
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Georgia Nephrology, Llc
Lawrenceville, Georgia, 30046-8761, United States
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Indago Research and Health Center
Hialeah, Florida, 33012, United States
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Infigo Clinical Research, Llc
Sanford, Florida, 32771, United States
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Kansas City Kidney Consultants (Arms, Dodge, Robinson, Wilber & Crouch, Inc.) - Kansas City
Kansas City, Missouri, 64111, United States
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Lcms Health University Medical Center New Orleans
New Orleans, Louisiana, 70112-3018, United States
-
Liberty Research Center
Dallas, Texas, 75237, United States
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Mendez Center for Clinical Research, LLC
Woodbridge, Virginia, 22191, United States
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Nephrology Associates
Fresh Meadows, New York, 11365, United States
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Nephrology Associates of Kentuckiana, PSC (NAK)
Louisville, Kentucky, 40205, United States
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Nephrology Associates, PC
Fresh Meadows, New York, 11365, United States
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Nephrology Associates, Pllc - Winston-Salem
Winston-Salem, North Carolina, 27103, United States
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Nephrology Consultants - Oklahoma City
Oklahoma City, Oklahoma, 73116-1516, United States
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Nephrology of the Golden Isles - Brunswick
Brunswick, Georgia, 31520, United States
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Northwest Louisiana Nephrology, Llc - Shreveport
Shreveport, Louisiana, 71101, United States
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Palm Beach Diabetes and Endocrine Specialists, PA (PBDES) - West Palm Beach Office
West Palm Beach, Florida, 33401, United States
-
Prx Research
Mesquite, Texas, 75149, United States
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Qway Research
Coconut Grove, Florida, 33133, United States
-
R&H Clinical Research
Katy, Texas, 27205, United States
-
Seacoast Kidney & Hypertension Specialists - Portsmouth Office
Portsmouth, New Hampshire, 03801, United States
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Southeast Renal Research Institute
Chattanooga, Tennessee, 37408, United States
-
Suny Downstate Medical Center - Parkside Dialysis Center
Brooklyn, New York, 11226-1508, United States
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Triad Internal Medicine
Asheboro, North Carolina, 27205, United States
-
Tufts University School of Medicine (Tusm) - Tufts Medical Center (Tmc) (Tufts-New England Medical Center)
Boston, Massachusetts, 02111, United States
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