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

Phase 3

• Conditions: Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality

• Registration Number: CTRI/2022/01/039125
• Lead Sponsor: Post Graduate Institute of Medical Education and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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 <=1 mg/kg on alternate days to maintain remission

Parents willing to give informed written consent

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 <-3 SD of that expected

Estimated glomerular filtration rate <60 ml/min/1.73 m2

Residing more than 200 km away or unwilling to come for regular follow-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse rate (patients per person year)Timepoint: At end of 12 months therapy

Secondary Outcome Measures

Name	Time	Method
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)