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Efficacy of a shorter duration of prednisolone treatment for children in relapse with steroid sensitive nephrotic syndrome: A randomised controlled study

Efficacy of short prednisolone treatment for relapse in children with steroid sensitive nephrotic syndrome: A randomised controlled study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/11/006345
Enrollment
114
Registered
2015-11-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Steroid Sensitive Nephrotic Syndrome

Interventions

Intervention1: Prednisolone: Prednisolone 2 mg/kg daily till remission followed by 1.5 mg/kg alternate day for 2 weeks for relapse Control Intervention1: Prednisolone: Prednisolone 2 mg/kg daily till

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with steroid sensitive nephrotic syndrome 2. Currently in relapse 3. Those who give written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with steroid resistant Nephrotic Syndrome 2. Patients with frequent relapses (defined as 2 or more relapses in 6 months or >3 in 12 months) or steroid dependence (defined as 2 consecutive relapses on alternate day therapy or within 2 weeks of discontinuation of therapy) 3. Known secondary cause (e.g. Hepatitis B, SLE, HSP) 4. Patients on alternate regimens with levamisole/cyclophospahmide/mycophenolate mofetil/azathioprine/rituximab 5. Patients who have not recieved atleast 4 weeks of daily steroids at 2 mg/kg followed by 4 weeks of 1.5 mg/kg alternate day steroids during initial episode

Design outcomes

Primary

MeasureTime frame
Proportion of children becoming frequently relapsing nephrotic syndromeTimepoint: 0 and 12 months

Secondary

MeasureTime frame
1. Time to first relpase 2. Relapse rates 3. Cumulative dose of steroids 4. Adverse effects of steroidsTimepoint: 0, 1 mo, 3 mo, 6 mo, 9 mo, 12 mo

Countries

India

Contacts

Public ContactProf Pankaj Hari

All India Institute of Medical Sciences

aiims.deepika@gmail.com9968859769

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 16, 2026