Phase
Condition
Circulation Disorders
Stress
Williams Syndrome
Treatment
Baxdrostat/dapagliflozin
Baxdrostat/Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants of any sex and gender must be ≥ 18 years of age at the time of signingthe informed consent.
Participants with eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
Participants with UACR > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) atscreening
Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg atthe randomisation visit.
Stable and maximum daily tolerated dose of either an ACE inhibitor or an ARB (notboth) for at least 4 weeks prior to the screening visit, if not medicallycontraindicated.
Participants with:
Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2.
Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2.
Contraceptive use should be consistent with local regulations regarding the methodsof contraception for those participating in clinical studies. Applicable to femaleparticipants.
Exclusion
Exclusion Criteria:
Systolic blood pressure > 180 mmHg, or diastolic blood pressure > 110 mmHg atscreening.
Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months beforescreening
Serum sodium < 135 mmol/L at the Screening Visit (values obtained within 4 weeksprior to screening or at the Screening Visit).
Diabetes mellitus:
T1DM at the screening visit
Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol)
New York Heart Association functional HF class IV at screening
Any use of mineralocorticoid receptor antagonists (such as spironolactone,eplerenone, or finerenone), aldosterone synthase inhibitors, potassium-sparingdiuretics (such as triamterene or amiloride), or potassium binders (such as sodiumzirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeksprior to screening
Stroke, transient ischaemic cerebral attack, valve implantation or valvereplacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, orhospitalisation for worsening HF within previous 3 months prior to randomisation.
Known severe hepatic impairment, defined as Child-Pugh Class C, based on recordsthat confirm documented medical history.
Documented history of adrenal insufficiency.
Any dialysis (including for acute kidney injury) within 3 months prior to thescreening
Any acute kidney injury within 3 months prior to the screening visit.
Prohibited concomitant medications
Study Design
Study Description
Connect with a study center
Research Site
Buenos Aires, C1060AAB
ArgentinaSite Not Available
Research Site
Buenos Aires 3435910, C1425AGC
ArgentinaSite Not Available
Research Site
Ciudad de Buenos Aires, C1425AGC
ArgentinaActive - Recruiting
Research Site
Mar del Plata, 7600
ArgentinaActive - Recruiting
Research Site
Mar del Plata 3430863, 7600
ArgentinaSite Not Available
Research Site
Rosario, S2000CVD
ArgentinaActive - Recruiting
Research Site
San Nicolás, B2900DMH
ArgentinaActive - Recruiting
Research Site
San Nicolás 3832624, B2900DMH
ArgentinaSite Not Available
Research Site
Pernik, 2300
BulgariaSite Not Available
Research Site
Pernik 728330, 2300
BulgariaSite Not Available
Research Site
Plovdiv, 4004
BulgariaSite Not Available
Research Site
Plovdiv 728193, 4004
BulgariaSite Not Available
Research Site
Sofia, 1756
BulgariaActive - Recruiting
Research Site
Sofia 727011, 1680
BulgariaSite Not Available
Research Site
Yambol, 8600
BulgariaActive - Recruiting
Research Site
Yambol 725578, 8600
BulgariaSite Not Available
Research Site
Courtice, Ontario L1E 2J5
CanadaActive - Recruiting
Research Site
Etobicoke, Ontario M9W 6V1
CanadaActive - Recruiting
Research Site
Stouffville, Ontario L4A1H2
CanadaActive - Recruiting
Research Site
Waterloo, Ontario N2T 0C1
CanadaActive - Recruiting
Research Site
Courtice 5930897, Ontario 6093943 L1E 2J5
CanadaSite Not Available
Research Site
Etobicoke 5950268, Ontario 6093943 M9W 6V1
CanadaSite Not Available
Research Site
Stouffville 6157718, Ontario 6093943 L4A1H2
CanadaSite Not Available
Research Site
Waterloo 6176823, Ontario 6093943 N2T 0C1
CanadaSite Not Available
Research Site
Montreal, Quebec H4J 1C5
CanadaActive - Recruiting
Research Site
Montreal 6077243, Quebec 6115047 H4J 1C5
CanadaSite Not Available
Research Site
Anyang-si, 14068
South KoreaSite Not Available
Research Site
Anyang-si 1846898, 14068
South KoreaSite Not Available
Research Site
Cheonan-si, 31151
South KoreaSite Not Available
Research Site
Goyang-si, 10380
South KoreaSite Not Available
Research Site
Goyang-si 1842485, 10380
South KoreaSite Not Available
Research Site
Seoul, 04401
South KoreaSite Not Available
Research Site
Seoul 1835848, 04401
South KoreaSite Not Available
Research Site
Badalona, 08916
SpainSite Not Available
Research Site
Badalona 3129028, 08916
SpainSite Not Available
Research Site
Pamplona, 31008
SpainSite Not Available
Research Site
Pamplona 3114472, 31008
SpainSite Not Available
Research Site
Valencia, 46010
SpainSite Not Available
Research Site
Valencia 2509954, 46010
SpainSite Not Available
Research Site
Kaohsiung City, 83301
TaiwanActive - Recruiting
Research Site
Kaohsiung City 1673820, 80756
TaiwanSite Not Available
Research Site
New Taipei City, 235
TaiwanActive - Recruiting
Research Site
New Taipei City 12908892, 235
TaiwanSite Not Available
Research Site
Taichung, 433004
TaiwanActive - Recruiting
Research Site
Taichung 1668399, 402
TaiwanSite Not Available
Research Site
Taipei, 110
TaiwanActive - Recruiting
Research Site
Taipei 1668341, 110
TaiwanSite Not Available
Research Site
Taoyuan, 333
TaiwanActive - Recruiting
Research Site
Taoyuan District, 333
TaiwanSite Not Available
Research Site
Taoyuan District 1667905, 333
TaiwanSite Not Available
Research Site
Bangkoknoi, 10700
ThailandActive - Recruiting
Research Site
Changwat Sara Buri, 18000
ThailandActive - Recruiting
Research Site
Changwat Sara Buri 1606418, 18000
ThailandSite Not Available
Research Site
Hat Yai, 90110
ThailandActive - Recruiting
Research Site
Hat Yai 1610780, 90110
ThailandSite Not Available
Research Site
Muang, 50200
ThailandActive - Recruiting
Research Site
Ratchathewi, 10400
ThailandActive - Recruiting
Research Site
Ratchathewi 7026885, 10400
ThailandSite Not Available
Research Site
Adana, 01060
Turkey (Türkiye)Active - Recruiting
Research Site
Adana 325363, 01060
Turkey (Türkiye)Site Not Available
Research Site
Adapazarı, 54290
Turkey (Türkiye)Active - Recruiting
Research Site
Adapazarı 752850, 54290
Turkey (Türkiye)Site Not Available
Research Site
Kahramanmaraş, 46040
Turkey (Türkiye)Active - Recruiting
Research Site
Kahramanmaraş 310859, 46040
Turkey (Türkiye)Site Not Available
Research Site
Kayseri, 38039
Turkey (Türkiye)Active - Recruiting
Research Site
Kayseri 308464, 38039
Turkey (Türkiye)Site Not Available
Research Site
Kocaeli, 41380
Turkey (Türkiye)Active - Recruiting
Research Site
Kocaeli 306970, 41380
Turkey (Türkiye)Site Not Available
Research Site
Kyiv, 01601
UkraineActive - Recruiting
Research Site
Kyiv 703448, 02002
UkraineSite Not Available
Research Site
Uzhhorod, 88018
UkraineActive - Recruiting
Research Site
Uzhhorod 690548, 88018
UkraineSite Not Available
Research Site
Vinnytsia, 21029
UkraineActive - Recruiting
Research Site
Vinnytsia 689558, 21029
UkraineSite Not Available
Research Site
Dundee, DD1 9SY
United KingdomActive - Recruiting
Research Site
Dundee 2650752, DD1 9SY
United KingdomSite Not Available
Research Site
Liverpool, L9 7AL
United KingdomActive - Recruiting
Research Site
Liverpool 2644210, L9 7AL
United KingdomSite Not Available
Research Site
London, E1 1FR
United KingdomActive - Recruiting
Research Site
London 2643743, E1 1FR
United KingdomSite Not Available
Research Site
Surprise, Arizona 85374
United StatesActive - Recruiting
Research Site
Surprise 5316428, Arizona 5551752 85374
United StatesSite Not Available
Research Site
Hollywood, Florida 33021
United StatesActive - Recruiting
Research Site
Port Charlotte, Florida 33952
United StatesActive - Recruiting
Research Site
Port Orange, Florida 32127
United StatesActive - Recruiting
Research Site
Hollywood 4158928, Florida 4155751 33021
United StatesSite Not Available
Research Site
Port Charlotte 4169130, Florida 4155751 33952
United StatesSite Not Available
Research Site
Port Orange 4169156, Florida 4155751 32127
United StatesSite Not Available
Research Site
Atlanta, Georgia 30344
United StatesActive - Recruiting
Research Site
Atlanta 4180439, Georgia 4197000 30344
United StatesSite Not Available
Research Site
Champaign, Illinois 61822
United StatesActive - Recruiting
Research Site
Champaign 4887158, Illinois 4896861 61822
United StatesSite Not Available
Research Site
Wichita, Kansas 67214
United StatesActive - Recruiting
Research Site
Wichita 4281730, Kansas 4273857 67214
United StatesSite Not Available
Research Site
Eatontown, New Jersey 07724
United StatesActive - Recruiting
Research Site
Eatontown 5097482, New Jersey 5101760 07724
United StatesSite Not Available
Research Site
Greenville, North Carolina 27834
United StatesActive - Recruiting
Research Site
Jacksonville, North Carolina 28546
United StatesActive - Recruiting
Research Site
New Bern, North Carolina 28562
United StatesActive - Recruiting
Research Site
Greenville 4469160, North Carolina 4482348 27834
United StatesSite Not Available
Research Site
Jacksonville 4473083, North Carolina 4482348 28546
United StatesSite Not Available
Research Site
New Bern 4481682, North Carolina 4482348 28562
United StatesSite Not Available
Research Site
Columbus, Ohio 43215
United StatesActive - Recruiting
Research Site
Columbus 4509177, Ohio 5165418 43215
United StatesSite Not Available
Research Site
Media, Pennsylvania 19063
United StatesActive - Recruiting
Research Site
Chester 4557137, Pennsylvania 6254927 19013
United StatesSite Not Available
Research Site
Media 4559575, Pennsylvania 6254927 19063
United StatesSite Not Available
Research Site
East Providence, Rhode Island 02914
United StatesActive - Recruiting
Research Site
East Providence 5221931, Rhode Island 5224323 02914
United StatesSite Not Available
Research Site
Arlington, Texas 76015
United StatesActive - Recruiting
Research Site
Pasadena, Texas 77504
United StatesActive - Recruiting
Research Site
San Antonio, Texas 78212
United StatesActive - Recruiting
Research Site
Arlington 4671240, Texas 4736286 76015
United StatesSite Not Available
Research Site
Pasadena 4717782, Texas 4736286 77504
United StatesSite Not Available
Research Site
San Antonio 4726206, Texas 4736286 78212
United StatesSite Not Available
Research Site
Woodbridge, Virginia 22192
United StatesActive - Recruiting
Research Site
Woodbridge 4794457, Virginia 6254928 22192
United StatesSite Not Available

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