| CTRI Number |
CTRI/2025/01/079159 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to see the effect of DAPAGLIFLOZIN in cirrhosis patients with Refractory Ascites |
|
Scientific Title of Study
|
RANDOMIZED CONTROL TRIAL OF SGLT-2 INHIBITOR (DAPAGLIFLOZIN) IN CIRRHOSIS PATIENTS WITH REFRACTORY ASCITES: A PILOT RCT DAPRA-CLD |
| Trial Acronym |
DAPRA-CLD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalimar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No. 127, Old OT Block, Department of Gastroenterology and Human Nutrition unit
South
DELHI
110029
India |
| Phone |
9868397211 |
| Fax |
|
| Email |
drshalimar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranjal SIngh |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
AB2 ward, Department of Gastroenterology, AIIMS, Ansari Nagar
South
DELHI
110029
India |
| Phone |
8826433805 |
| Fax |
|
| Email |
pranjal96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranjal SIngh |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
AB2 ward, Department of Gastroenterology, Ansari Nagar
DELHI
110029
India |
| Phone |
8826433805 |
| Fax |
|
| Email |
pranjal96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Gastroenterology, All India Institute of Medical Sciences, Ansari nagar, New Delhi-110029, Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Department of Gastroeneterology, Ansari Nagar, New Dlehi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shalimar |
All India Institute of Medical Sciences |
Department of Gastroeneterology, Ansari Nagar
South
DELHI |
9868397211
drshalimar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dapagliflozin (10 mg/day) plus standard of care |
Dapagliflozin 10mg/day will be given to the subject with the standard of care. Standard medical therapy will include dietary restriction of sodium and treatment with diuretics.
Duration 3 months |
| Comparator Agent |
standard of care |
Standard medical therapy will include dietary restriction of sodium and treatment with diuretics.
Duration: 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Cirrhosis patients with refractory ascites with Child-Turcotte-Pugh B7-C11 class Hepatic Cirrhosis (moderate-severe impaired liver function) |
|
| ExclusionCriteria |
| Details |
Portal vein thrombosis
Hepatocellular carcinoma.
Active alcoholism with last alcohol intake 1 month back
Gastrointestinal bleeding in the preceding 1 month
Overt hepatic encephalopathy in the preceding 1-month
Documented hypoglycaemia in the preceding 1-month
Serum sodium less than 125 meq/L
History of skeletal fracture in the preceding year or any past history of fragility fracture
History of peripheral vascular disease
Acute kidney injury as defined by the International Club of Ascites criteria
Spontaneous Bacterial Peritonitis within 1-month preceding the study
Anatomic urologic defects that predispose to urinary tract infection
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 either the APASL or CANONIC criteria
Treatment with drug with known effects on systemic and renal hemodynamics within 7 days of inclusion except beta-blockers
Patients opting for a liver transplant or TIPS
Refusal to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of control of ascites at 3 months between the 2 groups |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in eGFR measured by MDRD-6 at 1, 2 and 3 months
2. Change in urine output at 2 -weeks, 1, 2 and 3 months
3. Changes in serum and 24-hour urine sodium at 2-weeks, 1, 2 and 3 months
4. Change in HbA1c at 3-months
5. Change in prognostic scores – MELD score and CTP score at 1, 2 and 3 months
6. Change in Hemodynamic Parameters: Cardiac Output, MAP and Systemic Vascular resistance at 3-months
7. Incidence of overt hepatic encephalopathy over 3-months
8. Incidence of AKI as per ICA criteria over 3-months
9. Incidence of SBP, UTI and other infections over 3-months |
1. 3 month
2. 3 month
3. 3 month
4. 3 month
5. 3 month
6. 3 month
7. 3 month
8. 3 month
9. 3 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dapagliflozin, a Sodium Glucose
Linked Transporter-2 (SGLT-2) inhibitor, used in Type 2 Diabetes Mellitus, is
known for its cardiovascular benefits (4), renal benefits (5) and has minimal
risk of hypoglycemia due to its insulin-independent mechanism of action (6).
Its natriuretic effects have shown promise in reducing hospitalizations in
heart failure patients, regardless of diabetes status (7). In a recent small
case series, SGLT-2 inhibitors, including dapagliflozin, have resulted in
improvements in fluid retention and serum sodium levels in patients with
cirrhosis, without causing acute kidney injury or encephalopathy (8).
However, there remains a dearth of
well-designed clinical trials evaluating the efficacy of dapagliflozin
specifically in cirrhosis patients with refractory ascites. Thus, the objective
of this randomized controlled study is to assess the efficacy of dapagliflozin
in cirrhosis patients with refractory ascites. |