A Study to Investigate the Effects of Zibotentan/Dapagliflozin Combination Compared to Dapagliflozin Alone in Adult Participants with Chronic Kidney Disease and High Proteinuria
This is a Phase II, multicentre, randomised, double-blind, active-controlled, 2-arm parallel group study to evaluate the efficacy, safety, and tolerability of zibotentan and dapagliflozin in FDC compared to dapagliflozin alone, given QD on top of SoC, in adult participants with CKD and high proteinuria, with or without T2DM. Participants who are not already on SGLT2i at screening will receive a 28 day run in intervention with SGLT2i (dapagliflozin) QD. All participants will undergo a 12-week double-blind period. At the end of the treatment visit, participants will discontinue the blinded study intervention and begin open-label dapagliflozin monotherapy until the conclusion of the 4-week safety follow-up period. The results of this study will provide clinical data on efficacy and safety of an innovation treatment in the new region (the Russian Federation), which will be an important additional data source for Zibotentan/Dapagliflozin FDC approval process in the Eurasian Economic Union.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
224
Participants will receive zibotentan/dapagliflozin in fixed-dose combination as per the arms they are randomized to
Participants will receive monotherapy dapagliflozin as per the arms they are randomized to
Research Site
Aramil, Russia
RECRUITINGResearch Site
Izhevsk, Russia
SUSPENDEDChange in log-transformed Urinary Albumin to Creatinine Ratio (UACR) from baseline
To estimate the efficacy of zibotentan and dapagliflozin in FDC versus dapagliflozin alone in reducing albuminuria
Time frame: At Week 12
Change in log-transformed Urinary Protein to Creatinine Ratio (UPCR) from baseline
To estimate the efficacy of zibotentan and dapagliflozin in FDC versus dapagliflozin alone in reducing proteinuria
Time frame: At Week 12
Change in systolic and diastolic blood pressure (BP) from baseline
To estimate the efficacy of zibotentan and dapagliflozin in FDC versus dapagliflozin alone in reducing systolic and diastolic BP
Time frame: At Week 12
Number of participants experiencing adverse events
To assess the safety and tolerability of treatment with zibotentan and dapagliflozin in FDC compared to dapagliflozin alone during 12 weeks of treatment and 4 weeks of safety follow-up
Time frame: From Week 1 (Day 1) until Follow-up visit (Week 18, Day 112)
AstraZeneca Clinical Study Information Center
CONTACT
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Research Site
Krasnoyarsk, Russia
RECRUITINGResearch Site
Moscow, Russia
SUSPENDEDResearch Site
Moscow, Russia
RECRUITINGResearch Site
Moscow, Russia
RECRUITINGResearch Site
Moscow, Russia
RECRUITINGResearch Site
Omsk, Russia
RECRUITINGResearch Site
Orenburg, Russia
RECRUITINGResearch Site
Perm, Russia
RECRUITING...and 5 more locations