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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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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

שלב 3דרושים 5,000 משתתפים771 אתרים42 מדינות

קטגוריות

לב וכלי דם55%נפרולוגיה ואורולוגיה43%מיילדות וגינקולוגיה3%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

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

תקציר

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

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.

מצבים רפואיים

  • Chronic Kidney Disease and Hypertension

זכאות

מיןהכול
גילאים18 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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).

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהQUADRUPLE (4)
גיוסדרושים 5,000 משתתפים

נותן חסות ושותפים

  • AstraZeneca נותן חסות

זרועות והתערבויות

  • 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.

התערבויות

  • תרופה Baxdrostat/dapagliflozin

    baxdrostat tablet dapagliflozin tablet

  • תרופה Placebo/dapagliflozin

    dapagliflozin tablet placebo tablet

מדדי תוצאה

  1. מדד תוצאה ראשוני

    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

    מסגרת זמן Up to 37 months

  2. מדד תוצאה משני

    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

    מסגרת זמן Up to 37 months

  3. מדד תוצאה משני

    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

    מסגרת זמן Up to 37 months

  4. מדד תוצאה משני

    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

    מסגרת זמן Up to 37 months

  5. מדד תוצאה משני

    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

    מסגרת זמן Up to 37 months

  6. מדד תוצאה אחר

    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

    מסגרת זמן Up to 37 months

תאריכים

תאריך התחלה3 במרץ 2025 (בפועל)
סיום ראשוני18 בדצמבר 2029 (משוער)
סיום18 בדצמבר 2029 (משוער)
פורסם לראשונה19 בדצמבר 2024 (בפועל)
עודכן לאחרונה26 באוגוסט 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהאוגוסט 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

664 אתרים מגייסים

Argentina

מתקןעירמדינה או אזורמצב
Research SiteCABAבוטל
Research SiteCABAמגייס
Research SiteCiudad Autonoma de Bs Asמגייס
Research SiteCiudad de Buenos Airesמגייס
Research SiteCiudad de Buenos Airesמגייס
Research SiteCórdobaבוטל
Research SiteCórdobaמגייס
Research SiteCórdobaמגייס
Research SiteCórdobaמגייס
Research SiteCórdobaמגייס
Research SiteCórdobaמגייס
Research SiteLa Plataמגייס
Research SiteLanusמגייס
Research SiteLanús Esteמגייס
Research SiteMar del Plataמגייס
Research SiteMar del Plataמגייס
Research SiteRosarioמגייס
Research SiteSan Nicolásמגייס
Research SiteSanta Feמגייס
Research SiteSantiago del Esteroמגייס
Research SiteTemperleyמגייס
Research SiteTemperleyבוטל

Australia

מתקןעירמדינה או אזורמצב
Research SiteAdelaideמגייס
Research SiteDarlinghurstהושלם
Research SiteElizabeth Valeמגייס
Research SiteGosfordמגייס
Research SiteNorth Tamworthמגייס
Research SitePerthמגייס
Research SiteSouthportמגייס
Research SiteSt Leonardsמגייס
Research SiteWollongongמגייס

Belgium

מתקןעירמדינה או אזורמצב
Research SiteAalstמגייס
Research SiteBrusselsמגייס
Research SiteGenkמגייס
Research SiteHasseltמגייס
Research SiteIeperמגייס
Research SiteJetteמגייס
Research SiteKortrijkמגייס
Research SiteLeuvenמגייס
Research SiteLiègeמגייס
Research SiteMechelenמגייס
Research SiteNamurמגייס
Research SiteRoeselareמגייס
Research SiteRonseמגייס
Research SiteSint-Truidenבוטל

Brazil

מתקןעירמדינה או אזורמצב
Research SiteBarretosמגייס
Research SiteBelémמגייס
Research SiteBrasíliaמגייס
Research SiteCampina Grande do Sulמגייס
Research SiteCampinasמגייס

721 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 26 באוגוסט 2026

    אתר נוסף

    2 sites added (771 total)

    769771

  2. 28 ביולי 2026

    אתר נוסף

    5 sites added (769 total)

    764769

מרשם: ClinicalTrials.gov · NCT########

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