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Clinical Trial Details

Trial ID: L0139
Source ID: NCT06610526
Associated Drug: Dapagliflozin
Title: A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: Dapagliflozin
Outcome Measures: Primary: 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., Up to a median follow-up time of 24 months | Secondary: Percentage change in UACR from baseline, Data is reported as descriptive statistics., 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., 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., Up to a median follow-up time of 24 months|Time to death from any cause, Data is reported as descriptive statistics., 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., 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, * 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., 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
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 700
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-23
Completion Date: 2027-04-27
Results First Posted:
Last Update Posted: 2025-04-03
Locations: Research Site, Beijing, 100034, China|Research Site, Beijing, 100044, China|Research Site, Beijing, 100068, China|Research Site, Beijing, 100191, China|Research Site, Beijing, 102206, China|Research Site, Changchun, 130021, China|Research Site, Changsha, 410011, China|Research Site, Dongguan, 523059, China|Research Site, Foshan, 528308, China|Research Site, Fuyang, 236012, China|Research Site, Fuzhou, 350001, China|Research Site, Ganzhou, 341099, China|Research Site, Harbin, 150000, China|Research Site, Hefei, 230601, China|Research Site, Hengyang, 421001, China|Research Site, Huaian, 223399, China|Research Site, Huizhou, 516001, China|Research Site, Jilin, 132011, China|Research Site, Jinan, 250014, China|Research Site, Jining, 272029, China|Research Site, Lanzhou, 730000, China|Research Site, Linyi, 276199, China|Research Site, Nanchang, 330006, China|Research Site, Nanjing, 210029, China|Research Site, Nanning, 530021, China|Research Site, Ningbo, 315010, China|Research Site, Shanghai, 200090, China|Research Site, Shenzhen, 518036, China|Research Site, Suzhou, 215004, China|Research Site, Taian, 271099, China|Research Site, Tianjin, 300121, China|Research Site, Wuhu, 241000, China|Research Site, Wuxi, 214023, China|Research Site, Xiamen, 361004, China|Research Site, Xian, 710000, China
URL: https://clinicaltrials.gov/show/NCT06610526