ZENITH High Proteinuria

  • Research type

    Research Study

  • Full title

    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



  • Contact name

    Manika Azad

  • Contact email


  • Sponsor organisation

    AstraZeneca AB

  • Research summary

    This is a clinical trial funded by AstraZeneca to assess the efficacy (whether it works) and safety of an investigational drug called zibotentan/dapaglifozin (which is a combination of two drugs) for the treatment of chronic kidney disease (CKD) in patients who have high levels of protein in the urine. Despite current standard therapy for CKD, some participants continue to experience decline in kidney function. For this reason, new medicines for these participants need to be developed.
    Participants in this study will be over 18 years of age and have CKD with high levels of protein or albumin (which is a type of protein) in the urine that meets the level needed to participate in the study. Patients must also be on current standard therapy for CKD. In some cases, standard therapy of a drug SGLT2i will be started prior to receiving the study drug. Suitable participants will be randomly assigned to either zibotentan/dapaglifozin or dapaglifozin alone (which is a standard therapy for CKD). Neither participants nor the study staff assessing them will know whether have received zibotentan/dapaglifozin or dapaglifozin alone. It is not certain that participants will directly benefit from the combination therapy above standard treatment. If the zibotentan/dapaglifozin combination works, the future benefit from the medication will prevent worsening of kidney disease over time.
    The study will last at least 24 months across three stages, including screening (to assess eligibility for the study), treatment and follow-up. There will be at least 14 visits conducted in the UK and other countries. The study will be conducted at commercial research sites, hospitals and GP/specialist clinics.
    During the study, participants will undergo various tests, including blood and urine tests, heart tracings (ECGs) and physical exams.
    Participants will also complete various questionnaires about their symptoms and medications.

  • REC name

    Yorkshire & The Humber - Sheffield Research Ethics Committee

  • REC reference


  • Date of REC Opinion

    2 Feb 2024

  • REC opinion

    Further Information Favourable Opinion