evamisole on alternate days compared to steroids made daily during infections to prevent disease relapses in patients with frequently relapsing nephrotic syndrome

Phase 3

• Conditions: Health Condition 1: null- Nephrotic Syndrome

• Registration Number: CTRI/2015/07/006002
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 138

Inclusion Criteria

a) Patients with idiopathic steroid responsive nephrotic syndrome with frequent relapses or steroid dependence in the preceding 6 months

b) Age at onset of frequent relapses or steroid dependence between 2 and 18 years

c) Prednisolone requirement <=1 mg/kg on alternate days to maintain remission

d) Parents willing to give informed written consent

Exclusion Criteria

a) Known etiology (e.g., systemic lupus erythematosus, IgA nephropathy, amyloidosis)

b) Prior therapy with levamisole, cyclosporine, tacrolimus or azathioprine

c) Therapy with oral or intravenous cyclophosphamide or intravenous rituximab in the preceding 6 months

d) Thrombocytopenia, leukopenia or deranged liver function tests

e) Known chronic infection (tuberculosis, HIV, hepatitis B or C)

f) Known malignancy

g) Severe malnutrition (WHO classification); body mass index >30 or height <-2 SD of that expected (NCHS)

h) Presence of cataract or glaucoma

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

j) Residing more than 100 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
Proportion of patients with frequent relapsesTimepoint: 1 year

Secondary Outcome Measures

Name	Time	Method
Adverse effects associated with therapy (costicosteroids: Cushingoid habitus, obesity, hypertension, glaucoma, cataract; levamisole: leukopenia, thrombocytopenia, rash, seizures)Timepoint: 1 year;Cumulative prednisolone doseTimepoint: 1 year;Frequency and type of infectionsTimepoint: 1 year;Frequency of relapsesTimepoint: 1 year;Growth velocityTimepoint: 1 year;Proportion of patients wiht infection associated relapsesTimepoint: 1 year;Proportion of patients with sustained remissionTimepoint: 1 year;Time to first relapseTimepoint: 1 year