A study to compare the effects of treatment with mycophenolate mofetil to levamisole in preventing disease recurrences (relapses) in children who show frequent relapses of nephrotic syndrome , a kidney disease characterized by protein losses in the urine

Randomized controlled trial to compare the efficacy and safety of mycophenolate mofetil versus levamisole in children with frequently relapsing nephrotic syndrome

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/02/002394

Enrollment

132

Registered

2012-02-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Nephrotic syndrome with frequent relapses or steroid dependence

Interventions

Intervention1: Mycophenolate mofetil: administered orally at 1000 mg/m2 daily in two divided doses for one year Control Intervention1: Levamisole: given as a single oral dose of 2.5 mg/kg on alternate

Eligibility

Inclusion criteria

Inclusion criteria: •Patients with idiopathic steroid responsive nephrotic syndrome with frequent relapses or steroid dependence in the preceding six months (Table 4) •Age at onset of frequent relapses or steroid dependence between 6 and 18 years •Prednisolone requirement •Parents willing to give informed written consent

Exclusion criteria

Exclusion criteria: •Known etiology (e.g., lupus erythematosus, IgA nephropathy, amyloidosis) •Prior immunosuppression: levamisole, MMF, cyclosporine, tacrolimus, azathioprine or rituximab •Therapy with oral or intravenous cyclophosphamide in the preceding 6 months •Thrombocytopenia, leukopenia or deranged liver function tests at enrolment •Known chronic infection (tuberculosis, HIV, hepatitis B or C) •Known malignancy •Grade IV protein energy malnutrition (Indian Academy Pediatrics Classification) •Body mass index >30; height •Estimated glomerular filtration rate •Residing more than 100 km away or unwilling to come for regular follow-up

Design outcomes

Primary

Measure	Time frame
Frequency of relapsesTimepoint: During 12 months	—

Secondary

Measure	Time frame
Cumulative prednisolone dose in one-yrTimepoint: During 12 months;Frequency of infectionsTimepoint: During 12 months;Frequency of leukopenia, thrombocytopenia, GI discomfort, diarrhea, pain, rash, seizuresTimepoint: During 12 months;Growth velocityTimepoint: During 12 months;Proportion of patients with frequent relapsesTimepoint: During 12 months;Proportion of patients with sustained remissionTimepoint: During 12 months;Proportions of T and B cell subsets (B and T naÃ¯ve and memory; T cytotoxic; T helper: Th1, Th2 and Th17; T regulatory cells) between groups and within groups, at baseline with values at 3, 6, 9 & 12 months and at first relapseTimepoint: During 12 months;Time to first relapseTimepoint: Within one year	—

Measure

Time frame

Cumulative prednisolone dose in one-yrTimepoint: During 12 months;Frequency of infectionsTimepoint: During 12 months;Frequency of leukopenia, thrombocytopenia, GI discomfort, diarrhea, pain, rash, seizuresTimepoint: During 12 months;Growth velocityTimepoint: During 12 months;Proportion of patients with frequent relapsesTimepoint: During 12 months;Proportion of patients with sustained remissionTimepoint: During 12 months;Proportions of T and B cell subsets (B and T naÃ¯ve and memory; T cytotoxic; T helper: Th1, Th2 and Th17; T regulatory cells) between groups and within groups, at baseline with values at 3, 6, 9 & 12 months and at first relapseTimepoint: During 12 months;Time to first relapseTimepoint: Within one year

—

Countries

India

Contacts

Public ContactArvind Bagga

All India Institute of Medical Sciences

arvindbagga@hotmail.com91-11-26593472

Outcome results

None listed

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