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A clinical trial comparing two-weekly versus four-weekly tapering of steroids in children with nephrotic syndrome

Two-weekly versus four-weekly tapering of steroids in children with frequently relapsing nephrotic syndrome: an open-label, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037436
Enrollment
60
Registered
2021-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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 tapering 2-weekly: After achieving remission, prednisolone would be given orally in a dose of 1.5 mg/kg on alternate days for 2 weeks, thereafter the dose would be tapered
thereafter the dose would be tapered by 0.25mg/kg every 4-weeks until a threshold dose of 0.5mg/kg or lower is achieved

Sponsors

Jawaharlal Nehru Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children with FRNS/SDNS on tapering prednisolone with or without levamisole 2.Age group 1-18 years

Exclusion criteria

Exclusion criteria: 1.Secondary nephrotic syndrome or late steroid resistance. 2.Use of immunosuppressive medications other than oral prednisolone and levamisole in the preceding 6 months. 3.Impaired renal function (s.cr >1.2mg/dL) at enrollment. 4.Steroid threshold >1mg/kg on alternate days or features of steroid toxicity. 5.Patients unlikely to follow up at this centre.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with favorable outcome (sustained remission or infrequent relapses)Timepoint: At 1-year after enrollment

Secondary

MeasureTime frame
1.Time to first relapse 2.Frequency of relapses at 6 and 12 months 3.Cumulative prednisolone requirement 4.Proportion with treatment failure 5.Therapy associated adverse eventsTimepoint: During 1-year follow up peroid

Countries

India

Contacts

Public ContactNaushad Ahmad

Jawaharlal Nehru Medical College, AMU

drkafzal@hotmail.com0571-2721182

Outcome results

None listed

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