A clinical trial to study the efficacy of daily versus every-other day levamisole therapy in children with frequently relapsing nephrotic syndrome

Efficacy, safety and pharmacokinetics of daily versus every other day levamisole therapy in children aged 2-18 years with frequently relapsing or steroid dependent nephrotic syndrome: A prospective open label randomized trial with blinded end point assessment

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039125

Enrollment

166

Registered

2022-01-04

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

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: Daily Levamisole therapy: Daily therapy with levamisole in dose of 2.5 mg/kg/day for 12 months Control Intervention1: Every other day levamisole therapy: Every other day levamisole ther

Eligibility

Inclusion criteria

Inclusion criteria: Patients with idiopathic steroid responsive nephrotic syndrome with frequent relapses or steroid dependence in the preceding 6-12 months Age at onset of frequent relapses or steroid dependence between 2 and 18 years Prednisolone requirement Parents willing to give informed written consent

Exclusion criteria

Exclusion criteria: Prior therapy with cyclosporine tacrolimus or intravenous rituximab Therapy with oral or intravenous cyclophosphamide, and MMF in the preceding 12 months Known secondary etiology (e.g. lupus erythematosus IgA nephropathy amyloidosis) Known chronic infection (tuberculosis HIV hepatitis B or C) Known malignancy epilepsy Thrombocytopenia leukopenia neutropenia or deranged liver function tests at enrolment Evidence of steroid toxicity: Cataract glaucoma body mass index >30 or height Estimated glomerular filtration rate Residing more than 200 km away or unwilling to come for regular follow-up

Design outcomes

Primary

Measure	Time frame
Relapse rate (patients per person year)Timepoint: At end of 12 months therapy	—

Secondary

Measure	Time frame
Cumulative prednisolone dose during studyTimepoint: At end of 12 months therapy;Frequency of leukopenia neutropenia thrombocytopenia rash seizures cushingoid habitus obesity hypertension glaucoma cataractTimepoint: At end of 12 months therapy;Proportion of patients with frequent relapsesTimepoint: At end of 12 months therapy;Time to first relapseTimepoint: During 1 to 12 months study period;To assess the serum levamisole level between daily versus alternate day therapy groupTimepoint: At various time points (1 month 3 month 6 month and 12 month of trial)	—

Measure

Time frame

Cumulative prednisolone dose during studyTimepoint: At end of 12 months therapy;Frequency of leukopenia neutropenia thrombocytopenia rash seizures cushingoid habitus obesity hypertension glaucoma cataractTimepoint: At end of 12 months therapy;Proportion of patients with frequent relapsesTimepoint: At end of 12 months therapy;Time to first relapseTimepoint: During 1 to 12 months study period;To assess the serum levamisole level between daily versus alternate day therapy groupTimepoint: At various time points (1 month 3 month 6 month and 12 month of trial)

—

Countries

India

Contacts

Public ContactDr Jitendra Meena

Post Graduate Institute of Medical Education and Research

jitendra.2544aiims@gmail.com7073181114

Outcome results

None listed

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