Skip to content

Usefulness of Tolvaptan tablet over Furosemide injection in reducing swelling in Nephrotic syndrome

Efficacy and safety of oral Tolvaptan versus intravenous Furosemide in childhood Nephrotic Syndrome with edema – an Open Labelled Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046590
Enrollment
70
Registered
2022-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality Health Condition 2: N041- Nephrotic syndrome with focal andsegmental glomerular lesions Health Condition 3: N048- Nephrotic syndrome with other morphologic changes Health Condition 4: N049- Nephrotic syndrome with unspecified morphologic changes Health Condition 5: N045- Nephrotic syndrome with diffuse mesangiocapillary glomerulonephritis Health Condition 6: N042- Nephrotic syndrome with diffuse membranous glomerulone

Interventions

Intervention1: Tolvaptan: Oral tolvaptan as single daily dose based on following weight for 48 hours - more than 15 kg body weight - 7.5 mg/day - 15-29.9 kg body weight - 15 mg/day - 30 kg body weig

Sponsors

Department of Pediatrics
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Nephrotic syndrome aged between 5 and 14 years with moderate to severe edema 2) Patients not responding to oral furosemide for up to 24 hours (decrease in 3% body weight or urine output 3) Parents willing to give informed written consent

Exclusion criteria

Exclusion criteria: 1) Patients with hypovolemia 2) Patients with cerebral venous sinus thrombosis 3) Serum sodium 140 meq/L 4) eGFR 5) SGOT/SGPT > 2 ULN

Design outcomes

Secondary

MeasureTime frame
• Percentage of weight loss over 48 hours • Serum sodium every 12 hourly for 48 hours • Urine and serum osmolality every 24 hours for 48 hours • Urine sodium/ potassium/ creatinine every 24 hours for 48 hours • Adverse effects Timepoint: 0 Hours 12 hours 24 hours 36 hours 48 hours

Primary

MeasureTime frame
Urine output over the first 48 hours (ml/kg/hr)Timepoint: 0 hours 12 hours 24 hours 36 hours 48 hours

Countries

India

Contacts

Public ContactDr Aarchie Gupta

Postgraduate Institute of Medical Education and Research

ktiewsoh@rediffmail.com8390880902

Outcome results

None listed

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