To compare the efficacy of torsemide and furosemide for edema control in patients with nephrotic syndrome

Efficacy of oral torsemide versus oral furosemide in management of edema in patients with nephrotic syndrome: an open-label superiority randomized controlled trial - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058799

Enrollment

Registered

2023-10-18

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: N00-N99- Diseases of the genitourinary system Health Condition 2: N040- Nephrotic syndrome with minor glomerular abnormality

Interventions

Intervention1: Torsemide: torsemide, administered orally in a dose of 0.25-0.5 mg/kg twice daily

Duration of treatment: 48 hours Control Intervention1: Furosemide: furosemide, administered orally in a dose of 1-1.5 mg/kg twice daily for 48 hours

Eligibility

Inclusion criteria

Inclusion criteria: 1. Idiopathic nephrotic syndrome at onset or in relapse state 2. 3 to 18-year-old, toilet trained 3. Moderate to severe edema (judged clinically)

Exclusion criteria

Exclusion criteria: 1. Secondary cause of nephrotic syndrome 2. Presence of hypovolemia 3. Unable to swallow tablet 4. Serum albumin 5. Acute kidney injury (AKI) 6. Chronic kidney disease with eGFR 7. Hypokalemia, hyponatremia or significant metabolic alkalosis or acidosis 8. Use of IV albumin in the last 48 hours 9. Use of oral/IV diuretic in the last 24 hours 10. Diarrhea or vomiting in the last 48 hours 11. Suspected or confirmed thrombosis 12. Previously enrolled in the same study

Design outcomes

Primary

Measure	Time frame
Urine outputTimepoint: Over 48 hours, starting from administration of first dose of the drug	—

Secondary

Measure	Time frame
proportion of patients with adequate diuresis (urine output more than 2ml/kg/hour), proportion of treatment failure, patients with adverse events, change in urine output & weight from baseline, natriuresis, free water clearance, change in serum electrolytes & creatinine.Timepoint: proportion of patients with adequate diuresis (urine output more than 2ml/kg/hour) at 48 hours. proportion of treatment failure at 48 hours. patients with adverse events at 48 hours. change in urine output & weight from baseline at 48 hours. natriuresis at 12,24,36,48 hours. free water clearance at 24, 48 hours. change in serum electrolytes & eGFR at 24, 48 hours. Rates, severity (CTCAE), relatedness to therapy (WHO-UMC) of adverse events (AE) & serious AE (SAE) at 48 hours.	—

Measure

Time frame

proportion of patients with adequate diuresis (urine output more than 2ml/kg/hour), proportion of treatment failure, patients with adverse events, change in urine output & weight from baseline, natriuresis, free water clearance, change in serum electrolytes & creatinine.Timepoint: proportion of patients with adequate diuresis (urine output more than 2ml/kg/hour) at 48 hours. proportion of treatment failure at 48 hours. patients with adverse events at 48 hours. change in urine output & weight from baseline at 48 hours. natriuresis at 12,24,36,48 hours. free water clearance at 24, 48 hours. change in serum electrolytes & eGFR at 24, 48 hours. Rates, severity (CTCAE), relatedness to therapy (WHO-UMC) of adverse events (AE) & serious AE (SAE) at 48 hours.

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Countries

India

Contacts

Public ContactTanvi Bindal

All India Institute of Medical Sciences

aditisinhaaiims@gmail.com9899145489

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026