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comparison of a levamisole drug use in two different durations and dose in treatment of frequently relapsing nephrotic syndrome

Comparison of Alternate day Levamisole vs Daily Levamisole therapy in children with frequently relapsing Nephrotic syndrome: An open labelled Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048452
Enrollment
30
Registered
2022-12-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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: use of daily levamisole therapy in frequently relapsing nephrotic syndrome vs alternate day levamisole therapy: Daily levamisole therapy(2.5mg/kg/day) with alternate day prednisolone (1

Sponsors

Dr Poonam Dalal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: children aged 2-14 yrs with frequently relapsing nephrotic syndrome will be enrolled

Exclusion criteria

Exclusion criteria: 1. Children with infrequent relapses. 2. Children with steroid resistant nephrotic syndrome defined by persistent proteinuria at 4 weeks after start of steroid treatment. 3. Children who have received any other steroid sparing agents like cyclophosphamide, mycophenolate mofetil and calcineurin inhibitors like cyclosporine or tacrolimus for frequent relapses 4.previous or current malignancy,DM type1,current liver disease or epileptic convulsions 5.hypersensitivity to levamisole or one of its substances(lactose) 6.congenital nephrotic syndrome or secondary nephrotic syndrome

Design outcomes

Primary

MeasureTime frame
success of levamisole therapy which will be defined as less than 2 relapses over a 6 month period while on alternate day or daily levamisoleTimepoint: 6 months

Secondary

MeasureTime frame
duration to first relapse and cumulative steroid dosage received within six months of start of interventionTimepoint: 6 months

Countries

India

Contacts

Public ContactRashmi KR

Pt.B.D.Sharma PGIMS Rohtak

drpoonam12@yahoo.com9992168645

Outcome results

None listed

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