NAFLD CirrhosisNCT05849220
Dapagliflozin in Non Alcoholic Fatty Liver Disease Associated Cirrhosis and Its Role in Preventing Development of Chronic Kidney Disease.
A study testing Dapagliflozin in people with NAFLD Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NAFLD Cirrhosis
- What is being tested?
- Dapagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteIndia
- Study dates
- 15 May 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years <70years
- 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.
- Valid Informed written consent
Who cannot join
- Hospitalized patients
- CTP-C patients
- Intrinsic/structural kidney disease, obstructive uropathy, ADPKD, Anatomic urologic defects that predispose to urinary tract infection
- History of organ transplantation
- Refractory Ascites
- Type 1 DM
Show all 20Show fewer
- History of hypoglycemic symptoms in the last 2 months
- Recurrent UTI
- Patient with HCC or portal vein thrombosis
- Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
- History of fracture in the preceding year
- Severe Hyponatremia (Na <125 MEq/L)
- Pregnancy or Lactating mother
- Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
- MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment
- Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomization
- Mixed ascites (additional etiology of ascites apart from portal hypertension)
- Any severe extra hepatic condition including respiratory and cardiac failure
- Acute-on-chronic liver failure as per the APASL criteria
- Refusal to give consent
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Ayush Jain, MD, 01146300000, jainayush2206@gmail.com
About this study
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.
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.
Read the 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.
- Conditions
- NAFLD Cirrhosis
- Being tested
- Dapagliflozin, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Dapagliflozin
Standard of CareOther
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin+Standard of Care | Experimental | Dapagliflozin Receives: Drug: Dapagliflozin; Other: Standard of Care |
| Standard of Care | Active comparator | Standard of Care Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants developing Chronic Kidney Disease at 1 yr defined as per KDIGO guidelines.
Measured: 1 year
Secondary outcomes (12)
Number of participants developing Chronic Kidney Disease.
Measured: 3 months
Number of participants developing Chronic Kidney Disease.
Measured: 6 months
Improvement in eGlomerular filtration rate (eGFR) at 3 months.
Measured: 3 months
Change in eGlomerular filtration rate (eGFR) at 6 months.
Measured: 6 months
Change in eGlomerular filtration rate (eGFR) at 12 months.
Measured: 12 months
Number of participants developing acute kidney disease at 3 months.
Measured: 3 months
Number of participants developing acute kidney disease at 6 months.
Measured: 6 months
Number of participants developing acute kidney disease at 12 months.
Measured: 12 months
Number of participants Discontinuing drug due to adverse effects.
Measured: 1 year
Number of participants with resolution of ascites - partial or complete at 3 months.
Measured: 3 months
Number of participants with resolution of ascites - partial or complete at 6 months.
Measured: 6 months
Number of participants with resolution of ascites - partial or complete at 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start15 May 2023 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLD CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849220
- Sponsor's protocol ID
- ILBS-Cirrhosis-57
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05849220
- Acronym / sponsor ID
- ILBS-Cirrhosis-57
- Conditions
- NAFLD Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin+Standard of Care | Experimental | Drug: Dapagliflozin, Other: Standard of CareDapagliflozin |
| Standard of Care | Active comparator | Other: Standard of CareStandard of Care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years <70years
- 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.
- Valid Informed written consent
Key exclusion criteria (20 listed)
- Hospitalized patients
- CTP-C patients
- Intrinsic/structural kidney disease, obstructive uropathy, ADPKD, Anatomic urologic defects that predispose to urinary tract infection
- History of organ transplantation
- Refractory Ascites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinDapagliflozin | Drug | Dapagliflozin+Standard of Care |
| Standard of CareStandard of Care | Other | Dapagliflozin+Standard of Care, Standard of Care |
Primary outcome
Number of participants developing Chronic Kidney Disease at 1 yr defined as per KDIGO guidelines.
Time frame: 1 year
12 secondary outcomes
Number of participants developing Chronic Kidney Disease.
Time frame: 3 months
Number of participants developing Chronic Kidney Disease.
Time frame: 6 months
Improvement in eGlomerular filtration rate (eGFR) at 3 months.
Time frame: 3 months
Change in eGlomerular filtration rate (eGFR) at 6 months.
Time frame: 6 months
Change in eGlomerular filtration rate (eGFR) at 12 months.
Time frame: 12 months
Number of participants developing acute kidney disease at 3 months.
Time frame: 3 months
Number of participants developing acute kidney disease at 6 months.
Time frame: 6 months
Number of participants developing acute kidney disease at 12 months.
Time frame: 12 months
Number of participants Discontinuing drug due to adverse effects.
Time frame: 1 year
Number of participants with resolution of ascites - partial or complete at 3 months.
Time frame: 3 months
Number of participants with resolution of ascites - partial or complete at 6 months.
Time frame: 6 months
Number of participants with resolution of ascites - partial or complete at 12 months.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dapagliflozin in people with NAFLD Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Ayush Jain, MD (01146300000, jainayush2206@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants developing Chronic Kidney Disease at 1 yr defined as per KDIGO guidelines. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.