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Clinical Trials List

Protocol NumberD6405C00002
Active

2024-04-15 - 2026-12-31

Phase II

Not yet recruiting6

Recruiting2

ICD-10N18.4

Chronic kidney disease, stage 4 (severe)

ICD-10N18.5

Chronic kidney disease, stage 5

ICD-10N18.6

End stage renal disease

ICD-10N18.9

Chronic kidney disease, unspecified

ICD-9585

Chronic renal failure

A Phase IIb, Multicentre, Randomised, Double-Blind, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Balcinrenone in Combination with Dapagliflozin Compared with Dapagliflozin in Patients with Chronic Kidney Disease and Albuminuria

  • Trial Applicant

  • Sponsor

    AstraZeneca AB

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 李威杰 無
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Tsung-Hsien Lin 無
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yen-Wen Wu 無
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 張浤榮 無
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator VIN-CENT Wu 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 許育瑞 無
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Kang-Ling Wang 臨床試驗科
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Hsi-Hsien Chen
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Chronic Kidney Disease and Albuminuria

Objectives

To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing albuminuria

Test Drug

capsule

Active Ingredient

Zibotentan/Dapagliflozin

Dosage Form

116

Dosage

0.25 mg/10 mg; 0.75 mg/10 mg

Endpoints

Relative change in UACR from baseline to Week 12

Inclution Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:
Age
1 Participant must be ≥ 18 years old, at the time of signing the informed consent.
Type of Participant and Disease Characteristics
2 Diagnosis of CKD and eGFR ≥ 25 to < 60 mL/min/1.73 m2 at screening (Visit 1)
(2021 CKD-EPI creatinine formula, analysed at central laboratory).
3 UACR > 100 mg/g (10 mg/mmol) to ≤ 5000 mg/g (500 mg/mmol) at screening (Visit 1)
(spot urine sample, analysed at central laboratory).
4 Serum potassium ≥ 3.5 mmol/L to ≤ 5.0 mmol/L at screening (Visit 1) (analysed at
central laboratory).
5 Participants treated with RAAS inhibitors must be on a stable dose for at least 4 weeks
before screening. Participants who cannot tolerate or are not treated with RAAS inhibitors
can also participate in the study.



Sex and Contraceptive/Barrier Requirements
6 Contraceptive use by females should be consistent with local regulations regarding the
methods of contraception for those participating in clinical studies.
(a) Females not of childbearing potential are defined as females who are either
permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral
salpingectomy), or who are postmenopausal. Females will be considered
postmenopausal if they have been amenorrhoeic for 12 months prior to the planned
date of randomisation without an alternative medical cause. The following age
specific requirements apply:
(i) Females < 50 years old are considered postmenopausal if they have been
amenorrhoeic for 12 months or more following cessation of exogenous hormonal
treatment and follicle-stimulating hormone levels in the postmenopausal range.
(ii) Females ≥ 50 years old are considered postmenopausal if they have been
amenorrhoeic for 12 months or more following cessation of all exogenous
hormonal treatment.
(b) Female participants of childbearing potential must use one highly effective form of
birth control. A highly effective method of contraception is defined as one that can

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
Cardiac, vascular, and renal conditions
1 Uncontrolled arterial hypertension (ie, mean of 3 consecutive measurements of
SBP > 160 mmHg or DBP > 100 mmHg) at screening (Visit 1).
2 Hypotension defined as mean of 3 consecutive measurements of SBP < 100 mmHg at
screening (Visit 1).
3 Acute coronary syndrome (myocardial infarction or unstable angina), stroke, transient
ischaemic attack within 12 weeks prior to randomisation (Visit 2).
4 Diagnosis of lupus nephritis or antineutrophil cytoplasmic antibody-associated vasculitis.
Other nephropathies that are unstable, or progress rapidly, or require cytotoxic or
immunomodulatory therapy.
5 Diagnosis of autosomal dominant polycystic kidney disease.
6 Recent (within 90 days prior to screening) or ongoing dialysis, or in the opinion of the
investigator likely need for dialysis within 3 months following randomisation (Visit 2).

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    300 participants

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