Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-12 @ 1:18 AM
Study NCT ID:
NCT05849220
Status:
UNKNOWN
Last Update Posted:
2023-05-08
First Post:
2023-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dapagliflozin in Non Alcoholic Fatty Liver Disease Associated Cirrhosis and Its Role in Preventing Development of Chronic Kidney Disease.
Sponsor:
Institute of Liver and Biliary Sciences, India
Organization:
Study Overview
Official Title:
Dapagliflozin in Non Alcoholic Fatty Liver Disease Associated Cirrhosis and Its Role in Preventing Development of Chronic Kidney Disease. A Randomized Controlled Trial.
Status:
UNKNOWN
Status Verified Date:
2023-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The role of Dapagliflozin in the improvement in CKD in both diabetic and non-diabetic patients has been evaluated in the past. SGLT2i have also been found to be beneficial in NAFLD patients in improving the liver function parameters. It is also known that cirrhotic patients are at a higher risk of developing CKD at 1 year when compared to non cirrhotics. With this study we aim to study the role Dapagliflozin in cirrhotic patients in reducing the development of CKD, its impact on cirrhotic cardiomyopathy and its role in improvement of metabolic profile and liver related outcomes.
Detailed Description:
Hypothesis: Investigator hypothesise that Use of Dapagliflozin in NAFLD-Cirrhotic patients with moderate ascites will prevent progression and development of chronic kidney disease, ameliorate metabolic dysfunction and facilitate resolution of ascites by its renoprotective, cardioprotective and metabolic effects
Aim: To evaluate the efficacy of Dapagliflozin in NAFLD-cirrhotic patients with moderate ascites in preventing progression and development of CKD
Methodology:
Study population:
* Age \> 18 years \<70 years
* Patient with NAFLD associated cirrhosis and moderate ascites
* Stable eGFR-(\>60 ml/min/1.73m2) calculated using MDRD-6 equation: eGFR (ml/min/1.73 m2) = 198 × \[serum creatinine (mg/dL)\]-0. 858 × \[age\]-0. 167 × \[0.822 if patient is female\] × \[serum urea nitrogen concentration (mg/dL)\]-0.
Study design: Monocentric open label randomised controlled study. The study will be conducted in Department of Hepatology, ILBS.
Study period: 1 year
Sample size: Based on the previous study, assuming that progression rate in standard arm for chronic kidney disease is 30% and with addition of Dapagliflozin Investigator expect that there will be an absolute reduction of 20% in progression, i.e. 10 % progression rate
* Alpha - 5%
* Power - 80
* 10 % dropout rate
* Investigator need to enrol approximately 144 patients with 72 patients in each arm allocated into two groups by block randomization method taking block size of 10.
Patients will be evaluated in OPD for stable eGFR (based on the creatinine value in the last 3 months)
Intervention Patients after screening for all exclusion criteria will be randomised into 2 arms (group-1, receiving Dapagliflozin) and (group-2, standard of care) in a ratio 1:1
Monitoring and assessment Both the groups will undergo baseline investigations including KFT, Urine routine and microscopy, LFT, Fibroscan liver and spleen, baseline 2decho, ECG, NTproBNP, biomarkers of inflammation, renal reserve and metabolic profile incuding Hba1c, FBS, S.lipid profile, waist circumference, HOMA-IR, BMI, Bone mineral density(DEXA), liver frailty index, 6 min walk test and hand grip analysis.
All the patients will be followed in OPD at 3 monthly intervals and biomarkers of renal reserve and inflammation will be repeated at 6 monthly interval.
STATISTICAL ANALYSIS: Continuous data- Student's t test
* Nonparametric analysis- Mann Whitney test
* Survival outcome By Kaplan-Meier method curve.
* For all tests, p≤ 0.05 will be considered statistically significant.
* Analysis will be performed using SPSS.
* The analysis will be done with intention to treat and per protocol analysis if applicable.
Aim: To evaluate the efficacy of Dapagliflozin in NAFLD-cirrhotic patients with moderate ascites in preventing progression and development of CKD
Methodology:
Study population:
* Age \> 18 years \<70 years
* Patient with NAFLD associated cirrhosis and moderate ascites
* Stable eGFR-(\>60 ml/min/1.73m2) calculated using MDRD-6 equation: eGFR (ml/min/1.73 m2) = 198 × \[serum creatinine (mg/dL)\]-0. 858 × \[age\]-0. 167 × \[0.822 if patient is female\] × \[serum urea nitrogen concentration (mg/dL)\]-0.
Study design: Monocentric open label randomised controlled study. The study will be conducted in Department of Hepatology, ILBS.
Study period: 1 year
Sample size: Based on the previous study, assuming that progression rate in standard arm for chronic kidney disease is 30% and with addition of Dapagliflozin Investigator expect that there will be an absolute reduction of 20% in progression, i.e. 10 % progression rate
* Alpha - 5%
* Power - 80
* 10 % dropout rate
* Investigator need to enrol approximately 144 patients with 72 patients in each arm allocated into two groups by block randomization method taking block size of 10.
Patients will be evaluated in OPD for stable eGFR (based on the creatinine value in the last 3 months)
Intervention Patients after screening for all exclusion criteria will be randomised into 2 arms (group-1, receiving Dapagliflozin) and (group-2, standard of care) in a ratio 1:1
Monitoring and assessment Both the groups will undergo baseline investigations including KFT, Urine routine and microscopy, LFT, Fibroscan liver and spleen, baseline 2decho, ECG, NTproBNP, biomarkers of inflammation, renal reserve and metabolic profile incuding Hba1c, FBS, S.lipid profile, waist circumference, HOMA-IR, BMI, Bone mineral density(DEXA), liver frailty index, 6 min walk test and hand grip analysis.
All the patients will be followed in OPD at 3 monthly intervals and biomarkers of renal reserve and inflammation will be repeated at 6 monthly interval.
STATISTICAL ANALYSIS: Continuous data- Student's t test
* Nonparametric analysis- Mann Whitney test
* Survival outcome By Kaplan-Meier method curve.
* For all tests, p≤ 0.05 will be considered statistically significant.
* Analysis will be performed using SPSS.
* The analysis will be done with intention to treat and per protocol analysis if applicable.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: