A Multicenter randomized controlled study of short steroid treatment for relapse of nephrotic syndrome.

Efficacy of low dose, short course prednisolone regimen for relapse of steroid sensitive nephrotic syndrome in children: A multicenter, randomized, placebo-controlled trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/041221

Enrollment

210

Registered

2022-03-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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: Low dose, short course prednisolone regimen: Daily oral prednisolone 30 mg/m2 (maximum 40 mg) in a single oral dose until remission (defined as urine protein nil or trace for 3 consecut

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with steroid sensitive nephrotic syndrome with at least one relapse in the preceding 24 months, apart from current relapse 2. Age between 2 and 18 years 3. In relapse when enrolled, presenting within 3 days of starting therapy 4. Parents willing to give informed written consent Additional criteria: Patients on the following immunosuppression: a) Levamisole b) MMF c) >6 months of cyclophosphamide (IV) >12 months of IV rituximab d) Calcineurin inhibitor

Exclusion criteria

Exclusion criteria: 1.Current or past history of steroid resistant nephrotic syndrome 2.Three or more relapses in the last 12 months 3. Current relapse on alternate day steroids 4. Therapy with oral or intravenous cyclophosphamide in the preceding 6 months or intravenous rituximab in the preceding 12 months 5. Immunosuppression plan likely to be changed in the next 12 months 6. Presentation with life-threatening infection (e.g., cellulitis, peritonitis, pneumonia) requiring hospital admission 7. Secondary nephrotic syndrome (e.g., lupus erythematosus, IgA nephropathy, amyloidosis) 8. Known chronic infection (tuberculosis, HIV, hepatitis B or C) 9. Known malignancy 10. Estimated glomerular filtration rate 11. Residing more than 100 km away or unwilling to come for regular follow-up

Design outcomes

Primary

Measure	Time frame
Time to first relapse (amended vide IEC approval dated 11.10.2022) Timepoint: 1 Year	—

Secondary

Measure	Time frame
1. Proportion with frequent relapses 2. Proportion of treatment failure 3. Frequency of relapses 4. Cumulative prednisolone requirement (mg/kg) 5. Therapy associated adverse events, including obesity, cushingoid habitus, cataract, glaucoma & hypertension 6. Growth velocity 7. Frequency & type of infectionsTimepoint: 1 Year	—

Countries

India

Contacts

Public ContactPankaj Hari

ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI

pankajhari@hotmail.com9560701175

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026