A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well baxdrostat taken with dapagliflozin works and how safe it is. It is for adults with long-term kidney disease and high blood pressure, and looks at kidney health and deaths from heart or blood vessel problems.
International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18 years old.
- Meet one of two kidney test patterns below. eGFR measures how well your kidneys filter blood. UACR and UPCR measure protein in urine.
- Have an eGFR of 30–59, plus a UACR of 30–5000 mg/g or a UPCR of 700–7000 mg/g. A UACR below 500 must come from the study’s central lab; UPCR must come from a local lab.
- Or have an eGFR of 60–75, plus a UACR of 500–5000 mg/g or a UPCR of 700–7000 mg/g. UPCR must come from a local lab.
- Have a history of high blood pressure. The top number must be at least 130 at screening or within the 4 weeks before it, and at least 120 when assigned to a study group.
- Take a steady dose of an ACE inhibitor or ARB—not both—for at least 4 weeks before screening. These are blood pressure medicines, and the dose must be the highest you can tolerate.
- Have blood potassium of 3.0–4.8 mmol/L if your eGFR is 45 or higher, or 3.0–4.5 mmol/L if your eGFR is below 45.
Who can't join
- Blood pressure above 180 for the top number or above 110 for the bottom number at screening.
- Blood potassium of 5.5 mmol/L or higher within the past 3 months, or blood sodium below 135 mmol/L at screening or within the 4 weeks before it.
- Type 1 diabetes, with limited exceptions: in the US, you must have taken an SGLT2 inhibitor for at least 4 months, had no diabetic ketoacidosis during that time, and have experience checking ketones. In Japan, you must have taken dapagliflozin 10 mg for at least 4 months with no diabetic ketoacidosis during treatment. Ketoacidosis is a dangerous buildup of acids in the blood.
- Type 2 diabetes that is not controlled, with HbA1c above 10.5% at screening or within the past 3 months. HbA1c measures average blood sugar.
- The most severe level of heart failure, called class IV, at screening; or a stroke, mini-stroke, heart valve procedure, neck artery procedure, sudden serious heart blood-flow problem, or hospital stay for worsening heart failure within 3 months before study group assignment.
- A history of adrenal glands not making enough hormones; or any sudden kidney injury or dialysis within 3 months before screening. Dialysis is a treatment that filters the blood.
- A past organ or bone marrow transplant, or a planned organ transplant within 6 months after study group assignment.
- A condition needing medicine that lowers immune activity throughout the body, unless it is ongoing treatment that has been steady for at least 3 months before the first visit.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent. 2. Participants with (a) or (b): a) eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND: * UACR ≥ 30 mg/g (3.39 mg/mmol) and \< 500 mg/g (56.5 mg/mmol) (central laboratory value only), or * UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or * UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only). (b) eGFR 60-75 mL/min/1.73 m² (local or central laboratory value) AND: * UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or * UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only) 3. \[obsolete\] 4. Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit. 5. Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit. 6. Participants with: 1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values) 2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR \< 45 mL/min/1.73 m2 (local or central laboratory values) Exclusion Criteria: 1. Systolic blood pressure \> 180 mmHg, or diastolic BP \> 110 mmHg at screening. 2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening. 3. Serum sodium \< 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit). 4\. Participants with T1DM will be excluded, except: 1. For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion. 2. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion. 5 Uncontrolled T2DM with HbA1c \> 10.5% (\> 91 mmol/mol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit). 6 New York Heart Association functional HF class IV at screening. 7 Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening heart failure within previous 3 months prior to randomisation. 8 Documented history of adrenal insufficiency. 9 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit. 10 Any acute kidney injury within 3 months prior to the Screening Visit. 11 History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant). 12 Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).
Study sites (133)
AL
- Research Site · Fairhope, AL 36532More trials in Fairhope
AZ
- Research Site · Surprise, AZ 85374More trials in Surprise
- Research Site · Tucson, AZ 85741More trials in Tucson
CA
- Research Site · Beverly Hills, CA 90211More trials in Beverly Hills
- Research Site · Canoga Park, CA 91303More trials in Canoga Park
- Research Site · Concord, CA 94520More trials in Concord
- Research Site · Fremont, CA 94538More trials in Fremont
- Research Site · Fullerton, CA 92835More trials in Fullerton
- Research Site · Inglewood, CA 90301More trials in Inglewood
- Research Site · Los Alamitos, CA 90720More trials in Los Alamitos
- Research Site · Los Angeles, CA 90073More trials in Los Angeles
- Research Site · San Diego, CA 92120More trials in San Diego
- Research Site · San Francisco, CA 94110More trials in San Francisco
- Research Site · Stanford, CA 94305More trials in Stanford
- Research Site · Tarzana, CA 91356More trials in Tarzana
CO
- Research Site · Arvada, CO 80002More trials in Arvada
- Research Site · Denver, CO 80220More trials in Denver
CT
- Research Site · New Britain, CT 06051More trials in New Britain
DC
- Research Site · Washington D.C., DC 20037More trials in Washington D.C.
FL
- Research Site · Boca Raton, FL 33487More trials in Boca Raton
- Research Site · Boynton Beach, FL 33435More trials in Boynton Beach
- Research Site · Edgewater, FL 32132More trials in Edgewater
- Research Site · Fort Lauderdale, FL 33316More trials in Fort Lauderdale
- Research Site · Hollywood, FL 33021More trials in Hollywood
- Research Site · Jacksonville Beach, FL 32250More trials in Jacksonville Beach
- Research Site · Lake City, FL 32055More trials in Lake City
- Research Site · Lakeland, FL 33805More trials in Lakeland
- Research Site · Melbourne, FL 32901More trials in Melbourne
- Research Site · Miami Lakes, FL 33014More trials in Miami Lakes
- Research Site · Ocoee, FL 34761More trials in Ocoee
- Research Site · Port Charlotte, FL 33952More trials in Port Charlotte
- Research Site · Port Orange, FL 32127More trials in Port Orange
- Research Site · Riverview, FL 33578More trials in Riverview
GA
- Research Site · Atlanta, GA 30328More trials in Atlanta
- Research Site · Augusta, GA 30904More trials in Augusta
- Research Site · Austell, GA 30106More trials in Austell
- Research Site · Brunswick, GA 31520More trials in Brunswick
- Research Site · Conyers, GA 30094More trials in Conyers
- Research Site · Decatur, GA 30030More trials in Decatur
- Research Site · East Point, GA 30344More trials in East Point
- Research Site · Lawrenceville, GA 30046More trials in Lawrenceville
- Research Site · Riverdale, GA 30274More trials in Riverdale
HI
- Research Site · Honolulu, HI 96814More trials in Honolulu
IA
- Research Site · Iowa City, IA 52242More trials in Iowa City
- Research Site · West Des Moines, IA 50266More trials in West Des Moines
ID
- Research Site · Idaho Falls, ID 83402More trials in Idaho Falls
IL
- Research Site · Champaign, IL 61822More trials in Champaign
- Research Site · Maywood, IL 60153More trials in Maywood
- Research Site · Rockford, IL 61107More trials in Rockford
IN
- Research Site · Evansville, IN 47714More trials in Evansville
- Research Site · Indianapolis, IN 46202More trials in Indianapolis
KS
- Research Site · Hutchinson, KS 67502More trials in Hutchinson
- Research Site · Kansas City, KS 66112More trials in Kansas City
- Research Site · Wichita, KS 67214More trials in Wichita
LA
- Research Site · Kenner, LA 70065More trials in Kenner
- Research Site · Metairie, LA 70006More trials in Metairie
- Research Site · West Monroe, LA 71291More trials in West Monroe
MA
- Research Site · Boston, MA 02114More trials in Boston
- Research Site · Boston, MA 02115More trials in Boston
- Research Site · Braintree, MA 02184More trials in Braintree
- Research Site · New Bedford, MA 02740More trials in New Bedford
- Research Site · Worcester, MA 01608More trials in Worcester
MD
- Research Site · Bethesda, MD 20889More trials in Bethesda
MI
- Research Site · Ann Arbor, MI 48109More trials in Ann Arbor
- Research Site · Detroit, MI 48202More trials in Detroit
- Research Site · Garden City, MI 48135More trials in Garden City
- Research Site · Saint Joseph, MI 49085More trials in Saint Joseph
MO
- Research Site · Kansas City, MO 64112More trials in Kansas City
- Research Site · Kansas City, MO 64151More trials in Kansas City
- Research Site · St Louis, MO 63136More trials in St Louis
NC
- Research Site · Greenville, NC 27834More trials in Greenville
- Research Site · Hickory, NC 28601More trials in Hickory
- Research Site · Jacksonville, NC 28546More trials in Jacksonville
- Research Site · Kinston, NC 28504More trials in Kinston
- Research Site · Morehead City, NC 28557More trials in Morehead City
- Research Site · New Bern, NC 28562More trials in New Bern
- Research Site · Raleigh, NC 27609More trials in Raleigh
- Research Site · Rocky Mount, NC 27804More trials in Rocky Mount
- Research Site · Sanford, NC 27330More trials in Sanford
- Research Site · Statesville, NC 28625More trials in Statesville
- Research Site · Wilmington, NC 28401More trials in Wilmington
- Research Site · Wilmington, NC 28412More trials in Wilmington
- Research Site · Winston-Salem, NC 27103More trials in Winston-Salem
NE
- Research Site · Norfolk, NE 68701More trials in Norfolk
NJ
- Research Site · Eatontown, NJ 07724More trials in Eatontown
NV
- Research Site · Las Vegas, NV 89109More trials in Las Vegas
NY
- Research Site · Albany, NY 12205More trials in Albany
- Research Site · Buffalo, NY 14203More trials in Buffalo
- Research Site · New York, NY 10016More trials in New York
OH
- Research Site · Canton, OH 44718More trials in Canton
- Research Site · Cincinnati, OH 45212More trials in Cincinnati
- Research Site · Cincinnati, OH 45219More trials in Cincinnati
- Research Site · Columbus, OH 43210More trials in Columbus
- Research Site · Columbus, OH 43213More trials in Columbus
- Research Site · Columbus, OH 43215More trials in Columbus
OR
- Research Site · Springfield, OR 97477More trials in Springfield
PA
- Research Site · Bridgeville, PA 15017More trials in Bridgeville
- Research Site · Butler, PA 16001More trials in Butler
- Research Site · Exton, PA 19341More trials in Exton
- Research Site · Langhorne, PA 19047More trials in Langhorne
- Research Site · Media, PA 19063More trials in Media
RI
- Research Site · East Providence, RI 02914More trials in East Providence
- Research Site · East Providence, RI 02915More trials in East Providence
- Research Site · Providence, RI 02904More trials in Providence
SC
- Research Site · Charleston, SC 29414More trials in Charleston
- Research Site · Columbia, SC 29203More trials in Columbia
- Research Site · Orangeburg, SC 29118More trials in Orangeburg
TN
- Research Site · Chattanooga, TN 37421More trials in Chattanooga
- Research Site · Knoxville, TN 37912More trials in Knoxville
- Research Site · Knoxville, TN 37938More trials in Knoxville
- Research Site · Nashville, TN 37232More trials in Nashville
TX
- Research Site · Arlington, TX 76015More trials in Arlington
- Research Site · Austin, TX 78726More trials in Austin
- Research Site · Austin, TX 78735More trials in Austin
- Research Site · Austin, TX 78751More trials in Austin
- Research Site · Dallas, TX 75230More trials in Dallas
- Research Site · Dallas, TX 75234More trials in Dallas
- Research Site · Dallas, TX 75246More trials in Dallas
- Research Site · Houston, TX 77004More trials in Houston
- Research Site · Houston, TX 77099More trials in Houston
- Research Site · Humble, TX 77346More trials in Humble
- Research Site · Lewisville, TX 75057More trials in Lewisville
- Research Site · Pasadena, TX 77504More trials in Pasadena
- Research Site · Pearland, TX 77584More trials in Pearland
- Research Site · San Antonio, TX 78212More trials in San Antonio
UT
- Research Site · South Salt Lake, UT 84115More trials in South Salt Lake
VA
- Research Site · Arlington, VA 22205More trials in Arlington
- Research Site · Manassas, VA 20110More trials in Manassas
- Research Site · Newport News, VA 23606More trials in Newport News
- Research Site · Richmond, VA 23249More trials in Richmond
- Research Site · Woodbridge, VA 22192More trials in Woodbridge
VT
- Research Site · Burlington, VT 05401More trials in Burlington
WA
- Research Site · Seattle, WA 98195More trials in Seattle