Tests baxdrostat with dapagliflozin in people with kidney disease and high blood pressure
Tests baxdrostat plus dapagliflozin in adults with kidney disease and high blood pressure.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Albany, Ann Arbor, Arlington, Arvada, Atlanta, Augusta, Austell, Austin, Bethesda, Beverly Hills, Boca Raton, Boston, Boynton Beach, Braintree, Bridgeville, Brunswick, Buffalo, Burlington, Butler, Canoga Park, Canton, Champaign, Charleston, Chattanooga, Cincinnati, Columbia, Columbus, Concord, Conyers, Dallas, Decatur, Denver, Detroit, East Point, East Providence, Eatontown, Edgewater, Evansville, Exton, Fairhope, Fort Lauderdale, Fremont, Fullerton, Garden City, Greenville, Hickory, Hollywood, Honolulu, Houston, Humble, Hutchinson, Idaho Falls, Indianapolis, Inglewood, Iowa City, Jacksonville, Jacksonville Beach, Kansas City, Kenner, Kinston, Knoxville, Lake City, Lakeland, Langhorne, Las Vegas, Lawrenceville, Lewisville, Los Alamitos, Los Angeles, Manassas, Maywood, Media, Melbourne, Metairie, Miami Lakes, Morehead City, Nashville, New Bedford, New Bern, New Britain, New York, Newport News, Norfolk, Ocoee, Orangeburg, Pasadena, Pearland, Port Charlotte, Port Orange, Providence, Raleigh, Richmond, Riverdale, Riverview, Rockford, Rocky Mount, Saint Joseph, San Antonio, San Diego, San Francisco, Sanford, Seattle, South Salt Lake, Springfield, St Louis, Stanford, Statesville, Sun City, Tarzana, Tucson, Washington D.C., West Des Moines, West Monroe, Wichita, Wilmington, Winston-Salem, Woodbridge, and Worcester, United StatesSee the 118 sites
- Phase
- Phase 3
Where in United States
- AlbanyAlbany, United StatesTaking people
- Ann ArborAnn Arbor, United StatesTaking people
- ArlingtonArlington, United StatesTaking people
- ArvadaArvada, United StatesTaking people
- AtlantaAtlanta, United StatesTaking people
- AugustaAugusta, United StatesNo longer taking part
- AustellAustell, United StatesTaking people
- AustinAustin, United StatesTaking people
- BethesdaBethesda, United StatesTaking people
- Beverly HillsBeverly Hills, United StatesTaking people
- Boca RatonBoca Raton, United StatesTaking people
- BostonBoston, United StatesNo longer taking part
- Boynton BeachBoynton Beach, United StatesTaking people
- BraintreeBraintree, United StatesTaking people
- BridgevilleBridgeville, United StatesTaking people
- BrunswickBrunswick, United StatesTaking people
- BuffaloBuffalo, United StatesTaking people
- BurlingtonBurlington, United StatesTaking people
- ButlerButler, United StatesTaking people
- Canoga ParkCanoga Park, United StatesNo longer taking part
- CantonCanton, United StatesTaking people
- ChampaignChampaign, United StatesTaking people
- CharlestonCharleston, United StatesTaking people
- ChattanoogaChattanooga, United StatesTaking people
- CincinnatiCincinnati, United StatesTaking people
- ColumbiaColumbia, United StatesTaking people
- ColumbusColumbus, United StatesTaking people
- ConcordConcord, United StatesTaking people
- ConyersConyers, United StatesTaking people
- DallasDallas, United StatesNo longer taking part
- DecaturDecatur, United StatesTaking people
- DenverDenver, United StatesNo longer taking part
- DetroitDetroit, United StatesTaking people
- East PointEast Point, United StatesTaking people
- East ProvidenceEast Providence, United StatesTaking people
- EatontownEatontown, United StatesTaking people
- EdgewaterEdgewater, United StatesTaking people
- EvansvilleEvansville, United StatesNo longer taking part
- ExtonExton, United StatesTaking people
- FairhopeFairhope, United StatesTaking people
- Fort LauderdaleFort Lauderdale, United StatesTaking people
- FremontFremont, United StatesTaking people
- FullertonFullerton, United StatesTaking people
- Garden CityGarden City, United StatesTaking people
- GreenvilleGreenville, United StatesTaking people
- HickoryHickory, United StatesNo longer taking part
- HollywoodHollywood, United StatesTaking people
- HonoluluHonolulu, United StatesNo longer taking part
- HoustonHouston, United StatesTaking people
- HumbleHumble, United StatesTaking people
- HutchinsonHutchinson, United StatesTaking people
- Idaho FallsIdaho Falls, United StatesTaking people
- IndianapolisIndianapolis, United StatesTaking people
- InglewoodInglewood, United StatesNo longer taking part
- Iowa CityIowa City, United StatesTaking people
- JacksonvilleJacksonville, United StatesTaking people
- Jacksonville BeachJacksonville Beach, United StatesTaking people
- Kansas CityKansas City, United StatesTaking people
- KennerKenner, United StatesNo longer taking part
- KinstonKinston, United StatesTaking people
- KnoxvilleKnoxville, United StatesTaking people
- Lake CityLake City, United StatesTaking people
- LakelandLakeland, United StatesTaking people
- LanghorneLanghorne, United StatesTaking people
- Las VegasLas Vegas, United StatesNo longer taking part
- LawrencevilleLawrenceville, United StatesTaking people
- LewisvilleLewisville, United StatesNo longer taking part
- Los AlamitosLos Alamitos, United StatesTaking people
- Los AngelesLos Angeles, United StatesTaking people
- ManassasManassas, United StatesNo longer taking part
- MaywoodMaywood, United StatesTaking people
- MediaMedia, United StatesTaking people
- MelbourneMelbourne, United StatesTaking people
- MetairieMetairie, United StatesTaking people
- Miami LakesMiami Lakes, United StatesNo longer taking part
- Morehead CityMorehead City, United StatesTaking people
- NashvilleNashville, United StatesTaking people
- New BedfordNew Bedford, United StatesTaking people
- New BernNew Bern, United StatesTaking people
- New BritainNew Britain, United StatesTaking people
- New YorkNew York, United StatesTaking people
- Newport NewsNewport News, United StatesTaking people
- NorfolkNorfolk, United StatesTaking people
- OcoeeOcoee, United StatesTaking people
- OrangeburgOrangeburg, United StatesTaking people
- PasadenaPasadena, United StatesTaking people
- PearlandPearland, United StatesNo longer taking part
- Port CharlottePort Charlotte, United StatesTaking people
- Port OrangePort Orange, United StatesTaking people
- ProvidenceProvidence, United StatesNo longer taking part
- RaleighRaleigh, United StatesTaking people
- RichmondRichmond, United StatesTaking people
- RiverdaleRiverdale, United StatesNo longer taking part
- RiverviewRiverview, United StatesTaking people
- RockfordRockford, United StatesTaking people
- Rocky MountRocky Mount, United StatesTaking people
- Saint JosephSaint Joseph, United StatesTaking people
- San AntonioSan Antonio, United StatesTaking people
- San DiegoSan Diego, United StatesNo longer taking part
- San FranciscoSan Francisco, United StatesNo longer taking part
- SanfordSanford, United StatesTaking people
- SeattleSeattle, United StatesTaking people
- South Salt LakeSouth Salt Lake, United StatesTaking people
- SpringfieldSpringfield, United StatesTaking people
- St LouisSt Louis, United StatesTaking people
- StanfordStanford, United StatesTaking people
- StatesvilleStatesville, United StatesTaking people
- Sun CitySun City, United StatesTaking people
- TarzanaTarzana, United StatesTaking people
- TucsonTucson, United StatesTaking people
- Washington D.C.Washington D.C., United StatesTaking people
- West Des MoinesWest Des Moines, United StatesTaking people
- West MonroeWest Monroe, United StatesTaking people
- WichitaWichita, United StatesTaking people
- WilmingtonWilmington, United StatesTaking people
- Winston-SalemWinston-Salem, United StatesTaking people
- WoodbridgeWoodbridge, United StatesTaking people
- WorcesterWorcester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06742723EU 2023-506460-14-00
- Record updated
- 6 November 2026
- Original description
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 pressureRead full original descriptionShow less
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
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
Inclusion: Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent; Participants with (a) or (b):; 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); [obsolete]; 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; Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit; Participants with:; Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values); 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: 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; Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening; Serum sodium < 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit); 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); Systolic blood pressure > 180 mmHg, or diastolic BP > 110 mmHg at screening; Participants with T1DM will be excluded, except:.