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Clinical Trials List

Protocol NumberD6972C00003
Active

2024-02-01 - 2028-12-31

Phase III

Recruiting11

ICD-10I10

Essential (primary) hypertension

ICD-9401.0

Malignant essential hypertension

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

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator YEN-HUNG LIN Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 郭風裕 Division of Cardiovascular Diseases
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shih-Hsien Sung Division of Cardiovascular Diseases
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ji-Tseng Fang Division of Nephrology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kuan-Cheng Chang Division of Cardiovascular Diseases
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsung-Hsien Lin Division of Cardiovascular Diseases
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 洪俊聲   Division of Cardiovascular Diseases
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張家築 Division of Nephrology
Kuang Tien General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 彭渝森 Division of Nephrology
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 翁國昌 Division of Cardiovascular Diseases
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Yao Huang
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Chronic Kidney Disease and High Blood Pressure

Objectives

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.

Test Drug

tablet

Active Ingredient

Baxdrostat (CIN-107)
DAPAGLIFLOZIN

Dosage Form

110
110

Dosage

1 mg、2 mg
10 mg

Endpoints

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

Inclution Criteria

Age
1 Participants of any sex and gender must be ≥ 18 years of age at the time of signing the
informed consent.



Type of Participant and Disease Characteristics
2 Participants with (a) or (b):
(a) eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND:
o UACR ≥ 30 mg/g (3.39 mg/mmol) and < 500 mg/g (56.5 mg/mmol) (central
laboratory value only), or
o UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or
central laboratory value), or
o 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:
o UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or
central laboratory value), or
o 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 of 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:
(a) Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2
(local or central laboratory values)
(b) Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2
(local or central laboratory values)



Results for eGFR, potassium, and sodium used for assessing inclusion/exclusion criteria
should be obtained on the same day, should be the most recent values within 4 weeks of
screening or at the Screening Visit, and should be either all local or all central laboratory
values (Section 8.3.4).

Exclusion Criteria

Medical Conditions
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 prior to
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:
(a) 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.
(b) 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 HF within previous 3 months prior to randomisation.
8 Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that
confirm documented medical history.
9 Documented history of adrenal insufficiency.

The Estimated Number of Participants

  • Taiwan

    45 participants

  • Global

    2500 participants

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