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A randomized controlled clinical trial to compare the efficacy of standard dose of steroids vs reduced dose in children with nephrotic syndrome

A randomized controlled clinical trial to compare the efficacy of standard dose of steroids vs reduced dose in treating relapses in children with steroid sensitive nephrotic syndrome - Stdvsred

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/013634
Enrollment
60
Registered
2018-05-03
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- Children with Steroid sensitive Nephrotic Syndrome with infrequent relapses

Interventions

Intervention1: Reduced dose of steroids for treatment of relapses in idiopathic Steroid sensitive nephrotic children as compared to standard doses: to determine if reducing the total dose of steroids

Sponsors

Suprita Kalra
Lead Sponsor
SK Patnaik
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: all children with idiopathic nephrotic syndrome on stable immunosuppression(either long term alternate day steroids,levamisole or mycophenolate mofetil) or on no immunosuppresion for last 6 months with infrequent relapses defined as less than 2 relapses in last 6 months

Exclusion criteria

Exclusion criteria: •children started on a steroid sparing agent in last 6 months due to frequent relapses or steroid dependence, •Children with steroid resistant nephrotic syndrome

Design outcomes

Primary

MeasureTime frame
Proportion of frequent relapsers on the reduced dose regime as compared to standard regime Number of relapses in children in whom steroid dose is reduced to 1mg/kg alternate day for 4 weeks instead of the standard 1.5 mg/kg/day alternate day in 6 months Timepoint: 6 months follow up of each child since enrollment

Secondary

MeasureTime frame
 Cumulative steroid dose in two groups for 6 months Timepoint: 6 months follow up of each child since enrollment

Countries

India

Contacts

Public ContactSuprita Kalra

Armed Forces Medical College

kalrasuprita@gmail.com9871467926

Outcome results

None listed

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