The purpose of this study is to describe the efficacy and safety information with dapagliflozin in Chinese patients with chronic kidney disease.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
731
Dapagliflozin by oral administration
Research Site
Beijing, China
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.
Data is reported as descriptive statistics.
Time frame: Up to a median follow-up time of 24 months
Percentage change in UACR from baseline
Data is reported as descriptive statistics.
Time frame: 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
Data is reported as descriptive statistics.
Time frame: 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
Data is reported as descriptive statistics.
Time frame: Up to a median follow-up time of 24 months
Time to death from any cause
Data is reported as descriptive statistics.
Time frame: 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
Data is reported as descriptive statistics.
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Changchun, China
Research Site
Dongguan, China
Research Site
Foshan, China
Research Site
Fuyang, China
Research Site
Fuzhou, China
...and 24 more locations
* The number and percent of subjects with SAE and DAE, and the total number of SAE and DAEs will be provided. * The result and the change from baseline of each clinical chemistry/haematology tests will be summarized at each scheduled visit using summary statistics based on the FAS.
Time frame: 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