A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease

AstraZeneca

Status and phase

Active, not recruiting

Phase 4

Conditions

Chronic Kidney Disease

Treatments

Drug: Dapagliflozin

Study type

Interventional

Funder types

Industry

Identifiers

NCT06610526

D169AC00008

Details and patient eligibility

About

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

Full 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.

Enrollment

731 patients

Sex

All

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

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
T1DM
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
Known blood-borne diseases
Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator, from the time of signing the informed consent throughout the study and 4 weeks thereafter, OR women who have a positive pregnancy test at enrolment OR women who are breast-feeding
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca personnel and/or site personnel)
Previous enrolled in the present study
Participation in another clinical study with a study intervention during the last month prior to enrolment
Inability of the patient, in the opinion of the investigator, to understand and/or comply with study intervention, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study