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Delaying initiation of steroid therapy in steroid sensitive nephrotic syndrome children with relapse to reduce steroid therapy usage

Defining relapse with asymptomatic seven-day nephrotic range proteinuria in steroid sensitive nephrotic syndrome to reduce steroid therapy usage: a prospective interventional study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078098
Enrollment
150
Registered
2024-12-13
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: N049- Nephrotic syndrome with unspecified morphologic changes

Interventions

Intervention1: Delaying steroid therapy in relapse of nephrotic syndrome: While the relapse in nephrotic syndrome is defined by 3 consecutive days of nephrotic range proteinuria, there is a dearth of

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Steroid sensitive nephrotic syndrome children aged 3 to 18 years with disease duration of more than 1 year and 3 consecutive days of nephrotic range proteinuria

Exclusion criteria

Exclusion criteria: Non adherence to urine protein diary maintenance, Development of edema within 3 days of onset of nephrotic range proteinuria, Severe infections mandating stress dose steroids, Steroid resistant nephrotic syndrome course in the past, Refusal of consent

Design outcomes

Primary

MeasureTime frame
In children with steroid sensitive nephrotic syndrome (SSNS) aged 3-18 years with 3 days of nephrotic range proteinuria, to estimate the proportion of children in whom steroid therapy is avoided by delaying the diagnosis of relapse till day 7 of asymptomatic nephrotic range proteinuria.Timepoint: day 7

Secondary

MeasureTime frame
To study the time to remissionTimepoint: 6 weeks;To compare the proportion of children in whom steroid therapy is avoided between infrequent relapsing nephrotic syndrome and frequent relapsing nephrotic syndrome/ steroid dependent nephrotic syndromeTimepoint: 6 weeks;To compare the proportion of children in whom steroid therapy is avoided between proteinuria associated with infections and without infectionsTimepoint: 6 weeks;To estimate the proportion of children in need for relapse therapy within 6 weeks of onset of proteinuriaTimepoint: 6 weeks

Countries

India

Contacts

Public ContactParaselli Saiteja

AIIMS, NEW DELHI

drpankaj.hari@gmail.com9560701175

Outcome results

None listed

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