An Interventional, Multicentre, Phase IV, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease

AstraZeneca34 sites in 1 country731 target enrollmentAugust 23, 2024

ConditionsChronic Kidney Disease

InterventionsDapagliflozin

DrugsDapagliflozin

Overview

Phase: Phase 4
Intervention: Dapagliflozin
Conditions: Chronic Kidney Disease
Sponsor: AstraZeneca
Enrollment: 731
Locations: 34
Primary Endpoint: Time to the first occurrence of any of the components of the composite: 50% sustained decline in eGFR or Reaching ESRD or CV Death or Renal Death.
Status: Active, not recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to describe the efficacy and safety information with dapagliflozin in Chinese patients with chronic kidney disease.

Detailed Description

This is an interventional, multicentre, Phase IV, single-arm, open-label study to investigate the efficacy and safety of dapagliflozin to prevent the progression of chronic kidney disease in Chinese adult patients.

Registry

clinicaltrials.gov

Start Date

August 23, 2024

End Date

May 31, 2027

Last Updated

3 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provision of signed informed consent prior to any study specific procedures
•Chinese Female or male aged ≥ 18 years at the time of consent
•eGFR ≥ 25 and ≤ 75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1
•Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥ 200 and ≤ 5000 mg/g at visit 1
•Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated

Exclusion Criteria

•Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or anti-neutrophil cytoplasmic antibodies-associated vasculitis
•Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
•History of organ transplantation
•Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
•New York Heart Association class IV Congestive Heart Failure at the time of enrolment
•MI, unstable angina, stroke or TIA within 12 weeks prior to enrolment
•Coronary revascularization (PCI or CABG) or valvular repair/replacement within 12 weeks prior to enrolment
•Any condition outside the renal and CV disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator´s clinical judgement
•Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma)
•Hepatic impairment (AST or ALT \> 3 × ULN; or total bilirubin \> 2 × ULN at time of enrolment). An solated increase in bilirubin in patients with known Gilbert's syndrome is not a reason for exclusion

Arms & Interventions

Dapagliflozin

Dapagliflozin 10 mg once daily

Intervention: Dapagliflozin

Outcomes

Primary Outcomes

Time to the first occurrence of any of the components of the composite: 50% sustained decline in eGFR or Reaching ESRD or CV Death or Renal Death.

Time Frame: Up to a median follow-up time of 24 months

Data is reported as descriptive statistics.

Secondary Outcomes

Percentage change in UACR from baseline(Up to a median follow-up time of 24 months)
Time to the first occurrence of any of the components of the composite: ≥ 50% sustained decline in eGFR or Reaching ESRD or Renal death(Up to a median follow-up time of 24 months)
Time to the first occurrence of either of the components of the composite: CV death or Hospitalization for heart failure(Up to a median follow-up time of 24 months)
Time to death from any cause(Up to a median follow-up time of 24 months)
Measure the change in eGFR over time from baseline to the end of treatment and from first on treatment measurement to end of treatment(Up to a median follow-up time of 24 months)
To describe the safety profile in Chinese adult patients with CKD treated with dapagliflozin: SAE, DAEs, and clinical chemistry/haematology parameters(From the administration of study intervention throughout the study until and including the patient's last visit, up to a median follow-up time of 24 months)