Clinical trial NCT06610526: A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Kidney Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-09-24
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: 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.
timeFrame: Up to a median follow-up time of 24 months
Secondary outcomes:
measure: Percentage change in UACR from baseline
timeFrame: Up to a median follow-up time of 24 months
measure: Time to the first occurrence of any of the components of the composite: ≥ 50% sustained decline in eGFR or Reaching ESRD or Renal death
timeFrame: Up to a median follow-up time of 24 months
measure: Time to the first occurrence of either of the components of the composite: CV death or Hospitalization for heart failure
timeFrame: Up to a median follow-up time of 24 months
measure: Time to death from any cause
timeFrame: Up to a median follow-up time of 24 months
measure: Measure the change in eGFR over time from baseline to the end of treatment and from first on treatment measurement to end of treatment
timeFrame: Up to a median follow-up time of 24 months
measure: To describe the safety profile in Chinese adult patients with CKD treated with dapagliflozin: SAE, DAEs, and clinical chemistry/haematology parameters
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changchun
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Dongguan
country: China
facility: Research Site
city: Foshan
country: China
facility: Research Site
city: Fuyang
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Ganzhou
country: China
facility: Research Site
city: Harbin
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Hengyang
country: China
facility: Research Site
city: Huaian
country: China
facility: Research Site
city: Huizhou
country: China
facility: Research Site
city: Jilin
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Jining
country: China
facility: Research Site
city: Lanzhou
country: China
facility: Research Site
city: Linyi
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nanning
country: China
facility: Research Site
city: Ningbo
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Suzhou
country: China
facility: Research Site
city: Taian
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Wuhu
country: China
facility: Research Site
city: Wuxi
country: China
facility: Research Site
city: Xiamen
country: China
facility: Research Site
city: Xian
country: China
facility: Research Site
Study officials:
References: