The purpose of the study is to assess efficacy, safety and tolerability of treatment with zibotentan and dapagliflozin in combination and dapagliflozin 10 mg as monotherapy in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) 20 mL/min/1.73 m^2 or more, and urinary albumin to creatinine ratio (UACR) 150 mg/g or more and 5000 mg/g or less. - ZENITH-CKD

Ageishi Yuji0 sites660 target enrollmentMarch 8, 2021

ConditionsChronic Kidney Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Chronic Kidney Disease
Sponsor: Ageishi Yuji
Enrollment: 660
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 8, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Ageishi Yuji

Eligibility Criteria

Inclusion Criteria

•Participants are eligible to be included in the study only if all of the following criteria apply:
•Diagnosis of CKD, defined as:
•(a) eGFR chronic kidney disease epidemiology collaboration (CKD\-EPI) 20 mL/min/1\.73 m^2 or more, and
•(b) UACR 150 or more and 5000 mg or less albumin/g creatinine, based on a single first morning void spot urine sample at screening.
•\- No current or prior (within 1 month of screening) medical treatment with an SGLT2i (sodium\-glucose co\-transporter 2 inhibitor) or any fixed dose combination with SGLT2i
•\- If ACEi and/or ARB and/or mineralocorticoid receptor agonist (MRA) are prescribed, the dose must be stable 4 weeks or more before screening. Participants who have been deemed unable to tolerate ACEi or ARB therapy due to allergy or complications can be enrolled
•\- No current or prior treatment within 6 months prior to screening with cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary kidney disease
•\- Body mass index (BMI) 40 kg/m^2 or less
•\- All participants should follow protocol defined contraceptives procedures

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply:
•\- Minimal change disease, unstable rapidly progressing renal disease, and/or renal disease requiring significant immunosuppression, autosomal dominant or autosomal recessive polycystic kidney disease.
•\- Participants with New York Heart Association classification functional heart failure (HF) class III or IV
•\- Acute coronary syndrome events within 3 months prior to screening
•\- Participants with a confirmed B\-type natriuretic peptide (BNP) 200 pg/mL or more, or NT\-proBNP 600 pg/mL or more (or BNP 400 pg/mL or more or NT\-proBNP 1200 pg/mL or more, respectively, if associated with atrial fibrillation measured by local laboratory at screening (Visit 1\)
•\- Participants with unstable HF requiring hospitalisation for optimisation of HF treatment and/or who have not been stable on HF therapy within 6 months prior to screening
•\- Heart failure due to cardiomyopathies that would primarily require specific other treatment: eg, cardiomyopathy due to pericardial disease, amyloidosis or other infiltrative diseases, cardiomyopathy related to congenital heart disease, primary hypertrophic cardiomyopathy, cardiomyopathy related to toxic or infective conditions
•\- High output HF
•\- Heart failure due to primary cardiac valvular disease/dysfunction, severe functional mitral or tricuspid valve insufficiency, or planned cardiac valve repair/replacement
•\- Participants with uncontrolled diabetes mellitus (HbA1c \> 12%), and with T1DM