Comparison of tapering of steroid treatment over 4 weeks versus 8 weeks in children with frequently relapsing nephrotic syndrome

Comparison of the efficacy of steroid tapering over 4-weeks with 8-weeks in children with frequently relapsing or steroid dependent nephrotic syndrome on a steroid-sparing agent presenting with a relapse - A non-inferiority randomised controlled trial - nil

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070629

Enrollment

150

Registered

2024-07-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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: Quick weekly tapering of steroids over 4 weeks: After standard treatment of relapse with daily prednisolone 2 mg/kg (max 60 mg) till remission followed by 4 weeks of alternate day predn

Eligibility

Inclusion criteria

Inclusion criteria: Children 1-18 years of age with frequently relapsing or steroid dependent nephrotic syndrome on a steroid-sparing agent (levamisole/ mycophenolate mofetil/calcineurin inhibitor) for the preceding 2 months Presenting with relapse

Exclusion criteria

Exclusion criteria: Children currently on/have received oral cyclophosphamide in the preceding 6 months Children currently on/have received rituximab in the preceding 6 months Children who do not achieve remission even after 6 weeks of prednisolone treatment for the current relapse (late steroid resistance) Infantile onset nephrotic syndrome, monogenic and secondary forms of nephrotic syndrome (lupus nephritis, membranous nephropathy, etc.) Patients with significant comorbidities like diabetes (type 1 or drug induced), glaucoma, avascular necrosis of hip, psychosis, etc. Patient already enrolled in the study will not be re-enrolled in a future relapse

Design outcomes

Primary

Measure	Time frame
Incidence rate of relapses during the 6-months follow-up periodTimepoint: 6 months post randomization	—

Secondary

Measure	Time frame
Incidence rate of relapses at 12-months post randomization Incidence rate of upper respiratory tract infection (URI)-triggered relapses at 6-months and 12-months post randomization Time to first relapse Time to treatment failure Sustained remission Cumulative steroid dose (in mg/kg) Steroid-related adverse events hsCRP levels (at enrolment and follow-up)Timepoint: monthly follow up for 12 months	—

Countries

India

Contacts

Public ContactDr Sudarsan K

Jawaharlal Institute of Post graduate Medical Education And Research JIPMER

sudarsanjipmer@gmail.com9855071507

Outcome results

None listed

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