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 States1,835 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 range18 Years – 95 Years
SexALL
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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).
✓. 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.