Refractory AscitesPhase 2NCT06919523
Clinical Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patients With Refractory Cirrhotic Ascites
A Phase 2 study testing Dapagliflozin 5mg in people with Refractory Ascites, run by Mansoura University.
Trial summary
The aim of this clinical trial is to evaluate the safety and efficacy of low dose dapagliflozin use along with standard care versus the standard care alone in improving the clinical outcomes of patients with cirrhotic refractory ascites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Ascites
- What is being tested?
- Dapagliflozin 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 15 Sep 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >18 years diagnosed with decompensated liver cirrhosis complicated with ascites grade 2.
- Refractory ascites defined as one of the following:
- Ascites cannot be mobilized despite adherence to low sodium diet of ≤88 mmol/day for ≥1 week and maximum diuretic treatment dose (spironolactone 400 mg/day or furosemide (160 mg/day).
- Recurrence can't be prevented by medical therapy, Re-appearance of grade 2 or moderate ascites with moderate symmetrical abdominal distention, or grade 3 with massive ascites with marked abdominal distention within 4 weeks of initial mobilization.
Who cannot join
- Presenting blood pressure below 90/60 or history of hypotension requires vasopressor treatment.
- History of recurrent urinary tract infections, defined by the occurrence of 2 or more acute UTIs within months or 3 within a year.
- History of hypersensitivity to SGLT2 inhibitors.
- History of diabetic ketoacidosis or presence of risk factors for DKA (i.e alcohol consumption, type 1 diabetes).
- Pregnant or lactating women.
- History of recurrent episodes of hypoglycemia defined as plasma glucose concentration <70mg/dL.
- Severe renal dysfunction defined as, eGFR <20 ml/min/1.73m2.
About this study
The aim of this clinical trial is to evaluate the safety and efficacy of low dose dapagliflozin use along with standard care versus the standard care alone in improving the clinical outcomes of patients with cirrhotic refractory ascites. The main question it aims to answer is the difference in ascites control between the two groups at the end of treatment defined as:
Complete response: Disappearance of ascites. Partial response: Presence of ascites not requiring LVP. No response: Presence of ascites requiring LVP. Researchers will compare intervention group receiving dapagliflozin 5m once daily for 3 months along with standard care versus standard care group to evaluate the effectiveness and safety of dapagliflozin in refractory ascites patients.
- Conditions
- Refractory Ascites
- Being tested
- Dapagliflozin 5mg, Standard care treatment
- Keywords
- Refractory ascites, Dapagliflozin
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 5mgDrug
Dapagliflozin 5m orally once daily for 3 months plus standard care (diuretics and Large volume paracentesis)
Standard care treatmentDrug
Diuretics and Large volume paracentesis as indicated
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin group | Experimental | Not described Receives: Drug: Dapagliflozin 5mg |
| Standard care only group | Active comparator | Not described Receives: Drug: Standard care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in ascites control between the two groups at the end of treatment
Complete response: Disappearance of ascites. Partial response: Presence of ascites not requiring LVP. No response: Presence of ascites requiring LVP.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory AscitesStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mansour, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919523
- Sponsor's protocol ID
- 2025-NM
- Status last verified
- Mar 2025
- First submitted
- 2 Apr 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patients With Refractory Cirrhotic Ascites
- ClinicalTrials.gov ID
- NCT06919523
- Acronym / sponsor ID
- 2025-NM
- Conditions
- Refractory Ascites
- Keywords
- Refractory ascites, Dapagliflozin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 9 Apr 2025 (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 aim of this clinical trial is to evaluate the safety and efficacy of low dose dapagliflozin use along with standard care versus the standard care alone in improving the clinical outcomes of patients with cirrhotic refractory ascites. The main question it aims to answer is the difference in ascites control between the two groups at the end of treatment defined as:
Complete response: Disappearance of ascites. Partial response: Presence of ascites not requiring LVP. No response: Presence of ascites requiring LVP. Researchers will compare intervention group receiving dapagliflozin 5m once daily for 3 months along with standard care versus standard care group to evaluate the effectiveness and safety of dapagliflozin in refractory ascites patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin group | Experimental | Drug: Dapagliflozin 5mg |
| Standard care only group | Active comparator | Drug: Standard care treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults >18 years diagnosed with decompensated liver cirrhosis complicated with ascites grade 2.
- Refractory ascites defined as one of the following:
Key exclusion criteria (7 listed)
- Presenting blood pressure below 90/60 or history of hypotension requires vasopressor treatment.
- History of recurrent urinary tract infections, defined by the occurrence of 2 or more acute UTIs within months or 3 within a year.
- History of hypersensitivity to SGLT2 inhibitors.
- History of diabetic ketoacidosis or presence of risk factors for DKA (i.e alcohol consumption, type 1 diabetes).
- Pregnant or lactating women.
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 |
|---|---|---|
| Dapagliflozin 5mgDapagliflozin 5m orally once daily for 3 months plus standard care (diuretics and Large volume paracentesis) | Drug | Dapagliflozin group |
| Standard care treatmentDiuretics and Large volume paracentesis as indicated | Drug | Standard care only group |
Primary outcome
Difference in ascites control between the two groups at the end of treatment
Time frame: 3 months
Complete response: Disappearance of ascites. Partial response: Presence of ascites not requiring LVP. No response: Presence of ascites requiring LVP.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin 5mg in people with Refractory Ascites, run by Mansoura University.
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 7 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: opening soon, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in ascites control between the two groups at the end of treatment (time frame: 3 months). 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 9 Apr 2025.