A Study to Investigate the Effects of Zibotentan/Dapagliflozin Combination Compared to Dapagliflozin Alone in Adult Participants With Chronic Kidney Disease and High Proteinuria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-07

Study Completion Date

2026-07-31

Brief Summary

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A Study to Investigate the Effects of Zibotentan/Dapagliflozin Combination Compared to Dapagliflozin Alone in Adult Participants with Chronic Kidney Disease and High Proteinuria (ZODIAC)

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease With High Proteinuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Zibotentan/Dapagliflozin dose A or Zibotentan/Dapagliflozin dose B

Drug dose is determined based on eGFR values. Participants will receive daily oral dose of zibotentan/dapagliflozin in fixed dose combination.

Group Type EXPERIMENTAL

Zibotentan/Dapagliflozin

Intervention Type DRUG

Participants will receive zibotentan/dapagliflozin in fixed-dose combination as per the arms they are randomized to

Dapagliflozin alone

Participants will receive daily oral dose of dapagliflozin.

Group Type ACTIVE_COMPARATOR

Dapagliflozin

* Clinically significant, unstable, or uncontrolled medical condition which in the Investigator's opinion makes it undesirable for the participant to participate in the study.
* Known hypersensitivity to dapagliflozin or zibotentan or any of the excipients of the investigational product. History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2i therapy or ERAs.
* NYHA class III or class IV HF.
* Participants hospitalised for HF and/or who have not been stable on HF therapy during the last 6 months prior to screening.
* HF due to cardiomyopathies that would primarily require other specific treatment.
* High output HF (eg, due to hyperthyroidism or Paget's disease).
* HF due to primary cardiac valvular disease/dysfunction, severe functional mitral or tricuspid valve insufficiency, or planned cardiac valve repair/replacement.
* Evidence of rales or jugular venous distention on physical examination.
* Type 1 diabetes mellitus.
* History of any life-threatening ventricular dysrhythmia (continuous or paroxysmal).
* Participants hospitalised for heart disease or cardiac procedures or for COVID-19 during the last 3 months prior to screening.
* History of solid organ transplantation or bone marrow transplant.
* Any condition with a life expectancy of less than 1 year based on investigator´s clinical judgment.
* Malignancy within the past 5 years. Exceptions to this criterion include non-melanoma skin cancer and curatively treated cervical carcinoma in situ.
* Significant liver disease as judged by the investigator.
* Renal replacement therapy or previous kidney transplant.
* Known history of significant drug or alcohol abuse within 12 months of screening.
* On treatment with strong or moderate CYP3A4 inducer.
* On systemic immunosuppression therapy other than prespecified stable maintenance therapy.
* Participants treated or expecting to be treated with tolvaptan (including as part of participation in a clinical trial), any other ERAs, or budesonide (where used to treat IBD or IgAN).
* Systolic blood pressure above 160 mmHg and/or below 90 mmHg.
* Significant impairment of liver function defined as AST or ALT \>3 x upper limit of normal (ULN) or Total serum bilirubin \>2 x ULN (an isolated increase in bilirubin in participants with known Gilbert's syndrome is not a reason for exclusion).
* NT-proBNP ≥ 600 pg/mL (or NT-proBNP ≥ 1200 pg/mL, if associated with atrial fibrillation) measured by local laboratory at screening.
* Any of the following results of echocardiography at screening:

* left ventricular ejection fraction (LVEF) \< 50%
* significant ventricular wall motion abnormality or severe cardiac valve abnormalities
* isolated pulmonary arterial hypertension (as defined by local clinical practice) or right ventricular failure; in the absence of left-sided HF
* Women who are pregnant, breast-feeding, or women with intent of getting pregnant.
* Women who are not willing to use adequate contraception or cannot, in the opinion of the Investigator, understand and/or comply with the study requirements regarding contraception.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No