Clinical Trials List
2024-12-01 - 2030-12-31
Phase III
Recruiting8
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
AZ
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Cheng-Chia Lee Division of Nephrology
- Guan-Hsing Chen Division of Nephrology
- 范佩君 Division of Nephrology
- 鄭昌錡 Division of Nephrology
- Ya-Chung Tian Division of Nephrology
- Chih-Shiang Chang Division of Nephrology
- 吳欣旭 Division of Nephrology
- Yung-Chang Chen Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林裕峯 Division of Nephrology
- 潘思宇 Division of Nephrology
- FAN-CHI CHANG Division of Nephrology
- - - Division of Nephrology
- 陳怡婷 Division of Nephrology
- CHUN-FU LAI Division of Nephrology
- YU-HSIANG CHOU Division of Nephrology
- 黃道民 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Chin Kao Division of Nephrology
- Te-Chao Fang
- I-WEN WU
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dapagliflozin
Dosage Form
116
Dosage
10 mg
Endpoints
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
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.
10 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
11 Any acute kidney injury within 3 months prior to the Screening Visit.
12 Known hypersensitivity to the study treatment (active substance or excipients).
13 History of organ transplant or bone marrow transplant, or planned organ transplant within
6 months following randomisation (including kidney transplant).
14 History or ongoing allergy/hypersensitivity, as judged by the Investigator, to SGLT2i (eg,
empagliflozin) or ASI.
15 Any clinical condition requiring systemic immunosuppression therapy other than
maintenance therapy (stable for at least 3 months prior to Visit 1).
16 Drug or alcohol abuse that in the Investigator’s judgement makes the participant a poor
candidate for the study.
The Estimated Number of Participants
-
Taiwan
60 participants
-
Global
5000 participants
