Chronic Kidney Disease Clinical Trial
Official title:
A Phase 2 Study to Evaluate the Efficacy and Safety of Lorundrostat Alone, and Lorundrostat in Combination With Dapagliflozin, in Adults With Hypertension and Chronic Kidney Disease With Albuminuria
This is a 2-part study evaluating the efficacy and safety of lorundrostat (an aldosterone synthase inhibitor [ASI]) 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) either in combination with dapagliflozin, or alone.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | January 2025 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Major Inclusion Criteria: 1. At Screening, UACR of 300-3500 mg/g, inclusive 2. At Screening, eGFRs of: Part A: =45 and <90 mL/min/1.73 m2 Part B: =30 and <45 mL/min/1.73 m2 3. At Screening, AOBP SBP of 135-180 mmHg, inclusive 4. AOBP SBP of 135-160 mmHg, inclusive, at Randomization (Part A) or Week 0 visit (Part B) 5. On a stable treatment with an ACEi or ARB for at least 2 months prior to Screening 6. At Screening, body mass index (BMI) of 18-45 kg/m2, inclusive Major Exclusion Criteria: Part A only: 1. Subjects with known hypersensitivity to dapagliflozin or any of its respective excipients 2. Previous treatment with dapagliflozin or other sodium-glucose cotransporter 2 inhibitor (SGLT2i) within 4 weeks prior to the Screening Visit Part A and Part B: 1. Diabetes mellitus with a glycosylated hemoglobin (HbA1c) >9% (>74.9 mmol/mol) at Screening 2. Medical history of active autoimmune disease or recent or anticipated need for immunosuppressive therapy 3. 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 4. Medical history of advanced liver disease, including cirrhosis 5. History of adrenal insufficiency or an abnormal ACTH stimulation test within 1 year prior to Screening 6. Use of epithelial sodium channel (ENaC) inhibitors or mineralocorticoid receptor antagonists (MRAs), including but not limited to amiloride, triamterene, spironolactone, eplerenone or finerenone from 4 weeks prior to the Screening Visit and during study participation. With exception of MRAs in primary aldosteronism. |
Country | Name | City | State |
---|---|---|---|
United States | Triad Internal Medicine | Asheboro | North Carolina |
United States | Tufts University School of Medicine (Tusm) - Tufts Medical Center (Tmc) (Tufts-New England Medical Center) | Boston | Massachusetts |
United States | Nephrology of the Golden Isles - Brunswick | Brunswick | Georgia |
United States | Southeast Renal Research Institute | Chattanooga | Tennessee |
United States | Balboa Nephrology Medical Group, Inc. (BNMG) - California Institute of Renal Research (CIRR) - Chula Vista | Chula Vista | California |
United States | Qway Research | Coconut Grove | Florida |
United States | ClinCept, LLC | Columbus | Georgia |
United States | Dallas Nephrology Associates (Dna) - Renal Disease Research Institute (Rdri) | Dallas | Texas |
United States | Balboa Nephrology Medical Group, Inc. (BNMG) - El Centro | El Centro | California |
United States | Nephrology Associates | Fresh Meadows | New York |
United States | Nephrology Associates, PC | Fresh Meadows | New York |
United States | Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thunderbird Office | Glendale | Arizona |
United States | Elixia Pines, LLC | Hollywood | Florida |
United States | Kansas City Kidney Consultants (Arms, Dodge, Robinson, Wilber & Crouch, Inc.) - Kansas City | Kansas City | Missouri |
United States | R&H Clinical Research | Katy | Texas |
United States | Academic Medical Research Institute (AMRI) - Los Angeles | Los Angeles | California |
United States | Nephrology Associates of Kentuckiana, PSC (NAK) | Louisville | Kentucky |
United States | E T Nephrology Associates - Lufkin | Lufkin | Texas |
United States | Gamma Medical Research, Inc | Mission | Texas |
United States | Elixia Central Florida, LLC | Orlando | Florida |
United States | Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thomas Office | Phoenix | Arizona |
United States | Elixia MKC, LLC | Pontiac | Michigan |
United States | Seacoast Kidney & Hypertension Specialists - Portsmouth Office | Portsmouth | New Hampshire |
United States | Chrysalis Clinical Research (CCR) | Saint George | Utah |
United States | Northwest Louisiana Nephrology, Llc - Shreveport | Shreveport | Louisiana |
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 | Nephrology Associates, Pllc - Winston-Salem | Winston-Salem | North Carolina |
United States | Mendez Center for Clinical Research, LLC | Woodbridge | Virginia |
Lead Sponsor | Collaborator |
---|---|
Mineralys Therapeutics Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part A: Change from baseline in automated office blood pressure (AOBP) SBP at Week 8 | baseline to Week 8 | ||
Primary | Part B: Incidence and severity of AEs | baseline to Week 8 | ||
Secondary | Part A: Change from Week 12 in AOBP SBP at Week 20 | Week 12 to Week 20 | ||
Secondary | Part A: Percent change from baseline in 24-hour urine albumin to creatinine ratio (UACR) at Week 8 | baseline to Week 8 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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