Dapagliflozin and Placebo in improvement of ascites in cirrhotic patients : Randomized, double-blind, placebo-controlled, crossover trial.

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20241016007

Enrollment

Registered

2024-10-16

Start date

2024-07-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis with ascites Ketoacidosis UTI Bone fracture

Interventions

1 tablet oral before meal,1 tablet oral before meal

Active Comparator Drug,Placebo Comparator Drug

Daplagliflozin,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years 2. Cirrhosis Child - Pugh Score B, C with ascites 3.Unchanged dosage of diuretic for 1 month prior to the trial

Exclusion criteria

Exclusion criteria: 1.eGFR less than 30 ml/min/1.73m2 2. Hyponatremia (Na<30 mmol/L) 3. Using SGLT2 inhibitors 12 weeks prior participate to the trial 4.Ketoacidosis 5. Allergy or Hypersensitivity to SGLT2 inhibitors 6. Active malignancy 7. Pregnancy

Design outcomes

Primary

Measure	Time frame
24 hour Urine sodium Day 28 (week 4) 24 hour Urine sodium	—

Secondary

Measure	Time frame
Urine volume Day 28 (week 4) Urine volume,Improve of Hyponatremia Day 28 (week 4) Sodium level	—

Countries

Thailand

Contacts

Public Contactnattaporn kongphakdee

Thammasat university

ldnal@hotmail.com0946459158

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026