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Clinical Trials List

Protocol NumberD4325C00010
Active

2023-11-10 - 2027-12-31

Phase III

Not yet recruiting8

Recruiting1

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 III, Randomised, Multicentre, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin Alone in Participants with Chronic Kidney Disease and High Proteinuria

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 彭渝森 無
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Ji-Tseng Fang 無
Linkou Chang Gung Medical Foundation

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 Yi wen chiu Division of Nephrology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 楊紹佑 無
National Taiwan University 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 Wen-Chin Lee 無
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 Hsi-Hsien Chen
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Ju Wu 無
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Chronic Kidney Disease

Objectives

To determine whether zibotentan and dapagliflozin in FDC is superior to dapagliflozin alone to slow decline in kidney function

Test Drug

capsule

Active Ingredient

Zibotentan/Dapagliflozin

Dosage Form

116

Dosage

0.25 mg/10 mg; 0.75 mg/10 mg

Endpoints

Change in eGFR from baseline to Month 24.

Inclution Criteria

Participants are eligible to be included in the study only if all of the following criteria apply at
screening Visit 1:
Age
1 Participant must be ≥ 18 years of age and of legal age of consent in the jurisdiction in
which the study is taking place, at the time of signing the informed consent.
Type of Participant and Disease Characteristics/Laboratory Parameters
2 Diagnosis of CKD, defined as:
(a) eGFR ≥ 20 and < 90 mL/min/1.73m2 by central laboratory at screening Visit 1, using
CKD-EPI 2021 formula (Inker et al 2021; Section 8.2.1).
AND
(b) UACR > 700 mg/g (> 79 mg/mmol) or UPCR > 1000 mg/g (> 113 mg/mmoL). This
value must be from one of the following:
(i) A local laboratory value obtained within 4 months prior to screening Visit 1, and
the participant must be in a usual state of health without any modifications to
RAASi (ACEi or ARB), MRA, or SGLT2i therapy. Note: PER ≥ 1000 mg/day
may be used for inclusion (instead of UPCR) if PER is used locally for
quantification.
(ii) A central laboratory value obtained at screening Visit 1.

Exclusion Criteria

Medical Conditions
1 Participants with New York Heart Association classification class III or class IV HF.
2 Participants hospitalised for HF during the last 6 months prior to screening.
3 Evidence of rales or jugular venous distention on physical examination.
4 Participants with type 1 diabetes mellitus.
5 History of any life-threatening ventricular dysrhythmia (continuous or paroxysmal).
6 Systolic blood pressure above 160 mmHg.
7 Systolic blood pressure below 90 mmHg.
8 Participants hospitalised for heart disease (myocardial infarction, angina, cerebrovascular
accident) or cardiac procedures (carotid surgery/plasty, coronary artery bypass
grafting/percutaneous coronary intervention/transcatheter aortic valve implantation, or
valve replacement) or for COVID-19 during the last 3 months prior to screening.
9 History of solid organ transplantation or bone marrow transplant.
10 History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2i
therapy (eg, dapagliflozin, canagliflozin, empagliflozin, or other SGLT2i) or ERAs (eg,
ambrisentan, atrasentan, bosentan, or other).
11 Any condition with a life expectancy of less than 2 years based on investigator´s clinical
judgment.
12 Malignancy within the past 5 years. Exceptions to this criterion include non-melanoma
skin cancer and curatively treated cervical carcinoma in situ.
13 Significant liver disease as judged by the investigator, or AST or ALT > 3 × ULN, or
TBL > 2 × ULN. An isolated increase in bilirubin in participants with known Gilbert’s
syndrome is not a reason for exclusion.
14 Known blood-borne diseases such as specified in Appendix C (category A and B).
15 Clinically significant, unstable, or uncontrolled medical condition as assessed by the
investigator.
16 Participants on renal replacement therapy or previous kidney transplant.
17 Known history of drug or alcohol abuse within 12 months of screening.

The Estimated Number of Participants

  • Taiwan

    100 participants

  • Global

    1800 participants

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