Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to D… (NCT06087835) | Clinical Trial Compass
Active — Not RecruitingPhase 3
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)
United States, Argentina, Australia1,835 participantsStarted 2023-11-07
Plain-language summary
This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria
Who can participate
Age range
18 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Diagnosis of CKD, defined as eGFR ≥ 20 and \< 90 mL/min/1.73 m2 and UACR \> 700 mg/g (\> 79 mg/mmol) or UPCR \> 1000 mg/g (\> 113 mg/mmoL).
. All female participants must have a negative serum pregnancy test result at screening.
. Female participants must be either
. Capable of giving signed informed consent
. Provision of signed informed consent prior to any study specific procedure.
. Provision of electronic informed consent prior to completion of the optional Study Participant Feedback Questionnaire (SPFQ).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form prior to collection of samples for optional genomics imitative research that supports the Genomic Initiative.
Exclusion criteria
. Participants with NYHA class III or class IV Congestive HF at the time of enrolment.
. Participants hospitalised for HF during the last 6 month prior to screening.
. Evidence of rales or jugular venous distention on physical examination.
. Participants with type 1 diabetes mellitus.
. History of any life-threatening ventricular dysrhythmia (continuous or paroxysmal).
. Blood pressure above 160 mmHg systolic.
. Blood pressure below 90 mmHg systolic.
. Participants hospitalised for heart disease or cardiac procedures or for COVID-19 during the last 3 months prior to screening.