| Trial ID: | L1519 |
| Source ID: | NCT05849220
|
| Associated Drug: |
Dapagliflozin
|
| Title: |
Dapagliflozin in Non Alcoholic Fatty Liver Disease Associated Cirrhosis and Its Role in Preventing Development of Chronic Kidney Disease.
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
NAFLD Cirrhosis
|
| Interventions: |
DRUG: Dapagliflozin|OTHER: Standard of Care
|
| Outcome Measures: |
Primary: Number of participants developing Chronic Kidney Disease at 1 yr defined as per KDIGO guidelines., 1 year | Secondary: Number of participants developing Chronic Kidney Disease., 3 months|Number of participants developing Chronic Kidney Disease., 6 months|Improvement in eGlomerular filtration rate (eGFR) at 3 months., 3 months|Change in eGlomerular filtration rate (eGFR) at 6 months., 6 months|Change in eGlomerular filtration rate (eGFR) at 12 months., 12 months|Number of participants developing acute kidney disease at 3 months., 3 months|Number of participants developing acute kidney disease at 6 months., 6 months|Number of participants developing acute kidney disease at 12 months., 12 months|Number of participants Discontinuing drug due to adverse effects., 1 year|Number of participants with resolution of ascites - partial or complete at 3 months., 3 months|Number of participants with resolution of ascites - partial or complete at 6 months., 6 months|Number of participants with resolution of ascites - partial or complete at 12 months., 12 months
|
| Sponsor/Collaborators: |
Sponsor: Institute of Liver and Biliary Sciences, India
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
144
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-05-15
|
| Completion Date: |
2024-03-30
|
| Results First Posted: |
|
| Last Update Posted: |
2023-05-08
|
| Locations: |
Institute of Liver & Biliary Sciences, New Delhi, Delhi, 110070, India
|
| URL: |
https://clinicaltrials.gov/show/NCT05849220
|
