NCT06742723ClinicalTrials.gov

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

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En resumen

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

Fase 35000 participantes buscados771 centros42 países

Categorías

Cardiovascular55%Nefrología y urología43%Obstetricia y ginecología3%

Registrado en 1 registro

ClinicalTrials.govNCT06742723Abrir este registro en ClinicalTrials.govSincronizado hace 4 semanas

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2024-12-19; recorded start 2025-03-03
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 764 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 5,000 participants (target), run at 771 sites, across 42 countries.

How this score is built

Enrolment36/40
5,000 participants (target)
Site count25/25
764 sites
Country count15/15
42 countries
Planned duration10/10
Planned over about 58 months
Sponsor scale10/10
AstraZeneca has led 991 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, HF events, or CV death in participants with CKD and HTN. This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin. Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred (N = 845) ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within 6 weeks of the PACD. This period can be extended by AstraZeneca. In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. Baxdrostat/placebo should not be administered without dapagliflozin: baxdrostat/placebo should be interrupted if dapagliflozin is interrupted (baxdrostat/placebo may be resumed with dapagliflozin, if dapagliflozin is resumed), and should be permanently discontinued if dapagliflozin is permanently discontinued. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.

Afecciones

Chronic Kidney Disease and Hypertension

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	18 Years – Sin máximo
Voluntarios sanos	No

Elegibilidad tal como figura en el registro

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).

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	Fase 3
Asignación	Aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	TREATMENT
Enmascaramiento	QUADRUPLE (4)
Inscripción	5000 participantes buscados

Patrocinador y colaboradores

AstraZeneca Patrocinador

Grupos e intervenciones

Baxdrostat/dapagliflozinEXPERIMENTAL
Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a lower dose of baxdrostat and standard dose dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.
Placebo/dapagliflozinPLACEBO_COMPARATOR
Patients will receive one dose of dapagliflozin comparator in combination with matching placebo daily.

Intervenciones

Fármaco Baxdrostat/dapagliflozin
baxdrostat tablet dapagliflozin tablet
Fármaco Placebo/dapagliflozin
dapagliflozin tablet placebo tablet

Variables de resultado

Variable de resultado principal
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, Heart Failure events(HF), or CV death.
Time to the first occurrence of any of the components of the composite of: Kidney disease progression * ≥ 50% sustained decline in eGFR * Onset of kidney failure: * Sustained eGFR \< 15 mL/min/1.73 m2 or * Chronic dialysis treatment or * Receiving a kidney transplant or * Death with a renal primary cause (death due to kidney failure when dialysis is not given) CV events * HF with or without hospitalisation * CV death
Plazo Up to 37 months
Variable de resultado secundaria
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure or CV death.
Time to the first occurrence of any of the components of the composite of: * ≥ 50% sustained decline in eGFR * Onset of kidney failure: * Sustained eGFR \< 15 mL/min/1.73 m2 or * Chronic dialysis treatment or * Receiving a kidney transplant or * Death with a renal primary cause (death due to kidney failure when dialysis is not given) * CV death
Plazo Up to 37 months
Variable de resultado secundaria
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of MACE (Major Adverse Cardiac Events).
Time to the first occurrence of any of the components of the composite of: CV (cardiovascular) death, HF (heart failure) with and without hospitalization, Myocardial Infraction, Stroke
Plazo Up to 37 months
Variable de resultado secundaria
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of CV (cardiovascular) death.
Time to the first occurrence of any of the components of the composite of CV (cardiovascular) death
Plazo Up to 37 months
Variable de resultado secundaria
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of all-cause death.
Time to the first occurrence of any of the components of the composite of all-cause death
Plazo Up to 37 months
Otra variable de resultado
To assess the safety and tolerability of baxdrostat/dapagliflozin compared with placebo/dapagliflozin.
Safety and tolerability will be evaluated in terms of the following endpoints: * Occurrence and time to first occurrence of AEs, SAEs, SAEs with outcome death, DAEs, possibly related AEs as assessed by Investigator. * Observed values, change from baseline and time to first treatment-emergent abnormality in laboratory parameters. * Observed values, change from baseline and time to first treatment-emergent abnormality in vital signs, ECG. * Occurrence and time to first occurrence of AESIs: hyperkalaemia, hyponatraemia, and hypotension events that require medical intervention. -Exposure to study treatment will be described
Plazo Up to 37 months

Fechas

Fechas
Fecha de inicio	3 de marzo de 2025 (real)
Finalización principal	18 de diciembre de 2029 (estimada)
Finalización	18 de diciembre de 2029 (estimada)
Primera publicación	19 de diciembre de 2024 (real)
Última actualización	26 de agosto de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	agosto de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

664 centros están en reclutamiento

Argentina

Argentina
Centro	Ciudad	Estado
Research Site	CABA	Retirado
Research Site	CABA	En reclutamiento
Research Site	Ciudad Autonoma de Bs As	En reclutamiento
Research Site	Ciudad de Buenos Aires	En reclutamiento
Research Site	Ciudad de Buenos Aires	En reclutamiento
Research Site	Córdoba	Retirado
Research Site	Córdoba	En reclutamiento
Research Site	Córdoba	En reclutamiento
Research Site	Córdoba	En reclutamiento
Research Site	Córdoba	En reclutamiento
Research Site	Córdoba	En reclutamiento
Research Site	La Plata	En reclutamiento
Research Site	Lanus	En reclutamiento
Research Site	Lanús Este	En reclutamiento
Research Site	Mar del Plata	En reclutamiento
Research Site	Mar del Plata	En reclutamiento
Research Site	Rosario	En reclutamiento
Research Site	San Nicolás	En reclutamiento
Research Site	Santa Fe	En reclutamiento
Research Site	Santiago del Estero	En reclutamiento
Research Site	Temperley	En reclutamiento
Research Site	Temperley	Retirado

Australia

Australia
Centro	Ciudad	Estado
Research Site	Adelaide	En reclutamiento
Research Site	Darlinghurst	Completado
Research Site	Elizabeth Vale	En reclutamiento
Research Site	Gosford	En reclutamiento
Research Site	North Tamworth	En reclutamiento
Research Site	Perth	En reclutamiento
Research Site	Southport	En reclutamiento
Research Site	St Leonards	En reclutamiento
Research Site	Wollongong	En reclutamiento

Belgium

Belgium
Centro	Ciudad	Estado
Research Site	Aalst	En reclutamiento
Research Site	Brussels	En reclutamiento
Research Site	Genk	En reclutamiento
Research Site	Hasselt	En reclutamiento
Research Site	Ieper	En reclutamiento
Research Site	Jette	En reclutamiento
Research Site	Kortrijk	En reclutamiento
Research Site	Leuven	En reclutamiento
Research Site	Liège	En reclutamiento
Research Site	Mechelen	En reclutamiento
Research Site	Namur	En reclutamiento
Research Site	Roeselare	En reclutamiento
Research Site	Ronse	En reclutamiento
Research Site	Sint-Truiden	Retirado

Brazil

Brazil
Centro	Ciudad	Estado
Research Site	Barretos	En reclutamiento
Research Site	Belém	En reclutamiento
Research Site	Brasília	En reclutamiento
Research Site	Campina Grande do Sul	En reclutamiento
Research Site	Campinas	En reclutamiento

En el registro figuran 721 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

26 de agosto de 2026
Centro añadido
2 sites added (771 total)
769771
28 de julio de 2026
Centro añadido
5 sites added (769 total)
764769

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06742723