A study to examine whether giving steroids in low dose daily is more effective than if given on alternate days, in controlling disease activity in patients with frequently relapsing nephrotic syndrome

Open label, randomized, controlled trial to compare the efficacy of daily therapy with low dose prednisolone versus standard therapy on alternate days in patients with frequently relapsing/steroid dependent nephrotic syndrome

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/01/017091

Enrollment

160

Registered

2019-01-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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: Prednisolone: Given daily at 0.15-0.2 mg/kg at 8.00 am for 18 months Control Intervention1: Prednisolone: Given on alternate days at dose of 0.5-0.6 mg/kg (standard treatment) for 18 mo

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 2-18 yr with frequently relapsing or steroid dependent nephrotic syndrome Written informed consent from parents

Exclusion criteria

Exclusion criteria: Steroid resistant nephrotic syndrome Congenital nephrotic syndrome Nephrotic syndrome secondary to systemic disease (systemic lupus erythematosus, IgA nephropathy, infection with HIV or hepatitis B or C) Estimated glomerular filtration rate below 60 ml/min/1.73 sq. m Recent (during the last 6-months) therapy with long term alternate day prednisolone for >3-months, levamisole, cyclophosphamide or mycophenolate mofetil History of therapy with cyclosporine, tacrolimus or rituximab Significant steroid toxicity, as defined by BMI >2 SDS; stage 2 hypertension; cataract, glaucoma; fasting glucose levels >100 mg/dl; history of steroid psychosis

Design outcomes

Primary

Measure	Time frame
The proportions of patients with infrequent relapsesTimepoint: 18 months	—

Secondary

Measure	Time frame
Time to first relapseTimepoint: 18 months;Time to frequent relapsesTimepoint: 18 months;Frequency of relapsesTimepoint: 18 months;Proportion of patients with sustained remissionTimepoint: 18 months;Proportion of patients with frequent relapsesTimepoint: 18 months;Frequency and types of infectionsTimepoint: 18 months;Patients with corticosteroid related adverse events, including reduced growth velocity, obesity, cushingoid features, hirsutism, hypertension, cataract and glaucomaTimepoint: 18 months	—

Measure

Time frame

Time to first relapseTimepoint: 18 months;Time to frequent relapsesTimepoint: 18 months;Frequency of relapsesTimepoint: 18 months;Proportion of patients with sustained remissionTimepoint: 18 months;Proportion of patients with frequent relapsesTimepoint: 18 months;Frequency and types of infectionsTimepoint: 18 months;Patients with corticosteroid related adverse events, including reduced growth velocity, obesity, cushingoid features, hirsutism, hypertension, cataract and glaucomaTimepoint: 18 months

—

Countries

India

Contacts

Public ContactAditi Sinha

All India Institute of Medical Sciences New Delhi

aditisinhaaiims@gmail.com9899145489

Outcome results

None listed

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