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

Ageishi Yuji0 个研究点目标入组 200 人开始时间: 2024年1月11日最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

Ageishi Yuji