Clinical Trials List
2024-02-01 - 2028-12-31
Phase III
Not yet recruiting5
Recruiting6
A Phase III, Randomised, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants with CKD and High Blood Pressure
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Trial Applicant
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Sponsor
ASTRAZENECA TAIWAN LIMITED
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Trial scale
Multi-Regional Multi-Center
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Update
2025/12/04
Investigators and Locations
Co-Principal Investigator
- 周銘霆 無
- Zhih-Cherng Chen 無
- 林志憲 無
- 李威杰 無
- 張瑋婷 無
- 蔣俊彥 無
- 施志遠 無
- 黃聖中 無
- Chia-Te Liao 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Ye-Hsu Lu 無
- 卓士傑 無
- Wei-Chung Tsai 無
- Chun-Yuan Chu 無
- Po-Chao Hsu 無
- Mei Yueh Lee 無
- 吳韋璁 無
- 黃天祈 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tzung-Dau Wang 無
- Hsien Li Kao 無
- 蔡承烜 無
- JEN-KUANG LEE 無
- 洪啟盛 無
- Chih-Fan Yeh 無
- VIN-CENT Wu 無
- 林柏志 無
- 賀立婷 無
- - - 無
- CHO-KAI WU 無
- HUNG-JU LIN 無
- 黃道民 無
- CHUN-FU LAI 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Yung-Ta Kao 無
- Tsung-Lin Yang 無
- Chien-Yi Hsu 無
- 陳志維 無
- 鄭宇倫 無
- 陳彥舟 無
- 蕭卜源 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Wen-Chung Yu 無
- 張俊欽 無
- 廖若男 無
- Tse-Min Lu 無
- 李慶威 無
- 黃偉銘 無
- Hao-min Cheng 無
- 吳承學 無
- 郭泠 無
- Tze-Fan Chao 無
- Shih-Hsien Sung 無
- 黃少嵩 無
- 蔡依霖 無
The Actual Total Number of Participants Enrolled
0 Not yet 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
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Dapagliflozin
Active Ingredient
Dapagliflozin
Dosage Form
tablets
Dosage
10 mg
Endpoints
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time.
Inclution Criteria
1. Participants of any sex and gender must be ≥ 18 years old, or older, at the time of signing the informed consent.
2. Participants with CKD and eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
3. Urine albumin creatinine ratio > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening
4. Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit
5. Stable and maximum tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to Screening Visit
6. Central laboratory serum potassium must meet the following criteria at the Screening Visit, based on screening eGFR:
o for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.8 mmol/L at the Screening Visit
o for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.5 mmol/L at the Screening Visit
Exclusion Criteria
1. Systolic blood pressure > 180 mmHg, or DBP > 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 at the Screening Visit, determined as per central laboratory.
4. Diabetes mellitus:
(a) T1DM at Screening Visit: (i) 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.
(ii) 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.
(b) Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol).
5. New York Heart Association functional HF class IV at screening.
6. 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.
7. Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
8. Any acute kidney injury within 3 months prior to the Screening Visit
9. History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
10. History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2 inhibitor (eg, empagliflozin) or ASI.
11. Any clinical condition requiring systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1.
12. Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone), potassium-sparing diuretics (such as triamterene or amiloride), or potassium binders (such as sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks prior to screening.
The Estimated Number of Participants
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Taiwan
45 participants
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Global
2500 participants
