A Phase III Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants with Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)

JRCT ID: jRCT2031230557

Registered date:11/01/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Chronic Kidney Disease and High Proteinuria
• Date of first enrollment: 15/02/2024
• Target sample size: 200
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,China,Japan,Denmark,Japan,France,Japan,Germany,Japan,India,Japan,Israel,Japan,Italy,Japan,Malaysia,Japan,Mexico,Japan,Netherlands,Japan,Norway,Japan,Philippines,Japan,Poland,Japan,Slovakia,Japan,South Africa,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,United Kingdom,Japan,United States of America,Japan,Vietnam,Japan
• Study type: Interventional

Intervention(s)

Zibotentan/dapagliflozin 0.25mg/10mg Fixed Dose Combination Once daily
Zibotentan/dapagliflozin 0.75mg/10mg Fixed Dose Combination Once daily
Dapagliflozin 10mg Once daily

Outcome(s)

• Primary Outcome: Change in eGFR from baseline to Month 24.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Participant must be 18 years or more of age at the time of signing the informed consent.

2. eGFR 20 or more and below 90 mL/min/1.73m2 by central laboratory at screening Visit 1, using CKD-EPI 2021 formula and UACR above 700 mg/g (above 79 mg/mmol) or UPCR above 1000 mg/g (above 113 mg/mmoL).

3. All female participants must have a negative serum pregnancy test result at screening.

4. Receiving RAASi therapy (ACEi or ARB), and for the patient maximum tolerated labelled daily dose, that has been stable for at least 4 weeks.

Exclude criteria

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. Participants with type 1 diabetes mellitus.

4. Systolic blood pressure above 160 mmHg.

5. Systolic blood pressure below 90 mmHg.

6. Participants hospitalised for heart disease or cardiac procedures or for COVID-19 during the last 3 months prior to screening.

7. History of solid organ transplantation or bone marrow transplant.

8. Malignancy within the past 5 years.

9. Significant liver disease.

10. Participants on renal replacement therapy or previous kidney transplant.

11. Participants on treatment with strong or moderate CYP3A4 inducer.

12. Participants on systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1.

13. Participants treated or expecting to be treated with tolvaptan, any other ERAs, or budesonide.

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT06087835