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To study safety of Tolvaptan for management of swelling in children with Nephrotic Syndrome who did not respond to Furosemide

Efficacy and safety of tolvaptan in oral furosemide refractory edema in Nephrotic Syndrome : a prospective interventional trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095042
Enrollment
33
Registered
2025-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Interventions

Intervention1: Tolvaptan: Tolavaptan will be given as once daily dose for 2 days ( total doses- 2) Weight till 15kg- 7.5mg per oral , once daily Weight 15 to 30kg- 15mg per oral, once daily Weight mor

Sponsors

APC PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: children with nephrotic syndrome with moderate to severe oedema

Exclusion criteria

Exclusion criteria: Hypovolemia, CSVT, sodium less than 125 or more than 140, eGFR less than 60, SGOT and SGPT more than 2 times upper normal limit, other diuretics

Design outcomes

Primary

MeasureTime frame
Urine output over 48 hours (ml/kg/hr) after adding TolvaptanTimepoint: 48 hours after intervention—

Secondary

MeasureTime frame
Percentage weight loss over the first 48 hours of combination therapyTimepoint: 48 hours;Urine and serum osmolality before and every 24 hours of therapyTimepoint: 48 hours;Serum copeptin levels before and after the tolvaptan therapyTimepoint: 48 hours—

Countries

India

Contacts

Public ContactShailza Mahajan

PGIMER

ktiewsoh@rediffmail.com9465863631

Outcome results

None listed

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