Status:
COMPLETED
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
Lead Sponsor:
Mineralys Therapeutics Inc.
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 sy...
Detailed Description
The study consists of up to a 2-week Screening period, a 2-week run-in period where subjects will either begin study provided dapagliflozin 10 mg or continue on their regularly prescribed SGLT2i, and ...
Eligibility Criteria
Inclusion
- Major
- 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
- Major
Exclusion
- Subjects with known hypersensitivity to lorundrostat or any of its respective excipients
- Subjects with known hypersensitivity to dapagliflozin or any of its respective excipients (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 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
- 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
- Medical history of advanced liver disease, including cirrhosis
- Medical history of active autoimmune disease or recent (within 30 days) or anticipated need for immunosuppressive therapy
- Diabetes mellitus with a glycosylated hemoglobin (HbA1c) \>10% (\>86 mmol/mol) at Screening
Key Trial Info
Start Date :
December 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06150924
Start Date
December 14 2023
End Date
April 23 2025
Last Update
July 8 2025
Active Locations (44)
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1
Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thunderbird Office
Glendale, Arizona, United States, 85306
2
Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thomas Office
Phoenix, Arizona, United States, 85016
3
Balboa Nephrology Medical Group, Inc. (BNMG) - California Institute of Renal Research (CIRR) - Chula Vista
Chula Vista, California, United States, 91910
4
Balboa Nephrology Medical Group, Inc. (BNMG) - El Centro
El Centro, California, United States, 92243