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Clinical Trials List

Protocol NumberD8790C00001
NCT Number(ClinicalTrials.gov Identfier)NCT07624305
Not yet recruiting

2026-08-15 - 2030-12-31

Phase III

Not yet recruiting16

A Phase III, Randomised, Double-blind, Study to Evaluate the Effect of Balcinrenone/Dapagliflozin Compared With Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Chronic Kidney Disease (Stage 3b and 4)

  • Trial Applicant

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/08/25

Investigators and Locations

Principal Investigator Wen-Chin Lee Division of Nephrology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 鍾牧圻 Division of Nephrology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 張家築 Division of Nephrology
Kuang Tien General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 王怡寬 Division of Nephrology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet 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 Not yet recruiting

Principal Investigator Hsi-Hsien Chen Division of Nephrology
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator VIN-CENT Wu Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 黃建維 Division of Nephrology
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 鄭暉騰 Division of General Internal Medicine
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

  • 高廷瑄 Division of General Internal Medicine
  • 蔡秉錡 Division of General Internal Medicine

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 徐邦治 Division of Nephrology
Hualien Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 王憲奕 Division of Nephrology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 彭渝森 Division of Nephrology
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 吳勝文 Division of Nephrology
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator YUNG-HO HSU Division of Nephrology
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 吳家麟 Division of Nephrology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Junne-Ming Sung
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Renal Insufficiency, Chronic

Objectives

旨在判定在標準照護 (SoC) 療法的基礎上每日服用一次 balcinrenone/dapagliflozin 膠囊，相較於 dapagliflozin，是否能降低慢性腎臟病第 3b 及第 4 期成人患者發生心血管 死亡、因腎衰竭死亡、腎衰竭、eGFR 相較基準期的長時間降幅 ≥ 50% 及心衰竭事件的風險。本試驗也將評估 balcinrenone/dapagliflozin 的安全性與耐受性。

Test Drug

膠囊劑
錠劑

Active Ingredient

balcinrenone/dapagliflozin
dapagliflozin

Dosage Form

130
110

Dosage

15 mg/10 mg
10 mg

Endpoints

判定 balcinrenone/dapagliflozin 在降低心血管 (CV) 死亡、因腎衰竭死亡、腎衰竭、eGFR 長時間降幅 ≥ 50% 及心臟衰竭 (HF) 事件風險方面，是否優於 dapagliflozin
此複合指標之任何組成事件首次發生前所經時間：
•CV 死亡
•因腎衰竭而死亡
•發生腎衰竭：
開始長期維持透析或
腎臟移植
•eGFR 相較基準期的降幅長時間 ≥ 50%
•HF（住院或未住院）a

Inclution Criteria

Inclusion Criteria:

Age ≥ 18 years
Diagnosis of CKD and at least one of the following:

eGFR ≥ 15 to < 45 mL/min/1.73 m2 AND: UACR ≥ 30 mg/g (central laboratory) or UACR ≥ 100 mg/g (local laboratory ) or UPCR ≥ 200 mg/g (local laboratory).
eGFR ≥ 15 to < 30 mL/min/1.73 m2 and UACR < 30 mg/g (local or central laboratory UACR value).
Serum/plasma K+ ≤ 5.0 mmol/L
Maximum tolerated dose of an ACEi or an ARB, unless contraindicated or not tolerated. The dose should be stable for at least 4 weeks before screening.

Exclusion Criteria

Exclusion Criteria:

Recent (within 90 days prior to screening) or ongoing dialysis, or likely to require dialysis within 3 months following randomisation
UACR ≥ 5000 mg/g or UPCR ≥ 7000 mg/g at screening.
SBP > 180 mmHg or DBP > 110 mmHg at screening.
SBP < 90 mmHg at screening.
HbA1c > 9% at screening
T1DM, except:

For US only: patients with T1DM treated with SGLT2i for at least 4 months prior to screening, without DKA during that period, and who have experience with ketone monitoring are eligible.
For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months prior to Screening, without DKA during the period of dapagliflozin treatment are eligible for inclusion.
Autosomal dominant polycystic kidney disease.
Major cardiac or valvular surgery, acute coronary syndrome (myocardial infarction or unstable angina), stroke, transient ischaemic attack within 12 weeks prior to screening.
Severe hepatic impairment (Child-Pugh Class C).
Adrenal insufficiency.
Clinically significant acute kidney injury within 12 weeks prior to the screening.
New York Heart Association functional HF class IV at screening, or hospitalisation for heart failure within 4 weeks prior to screening.
Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months) prior to screening.
Solid organ or bone marrow transplant or a plan for transplant within 6 months following randomisation.
Any use of the following medications and supplements:

MRAs
Aldosterone analogues
Aldosterone synthase inhibitors
Any use of potassium binders within 2 weeks prior to screening. Use is allowed after randomisation.
Strong or moderate inducers or inhibitors of CYP3A4, prohibited at least one week prior to randomisation

The Estimated Number of Participants

  • Taiwan

    208 participants

  • Global

    2800 participants

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