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A trial to compare the effectiveness of two different drugs for the treatment of children with nephrotic syndrome.

Randomized controlled trial to compare the efficacy of daily Levamisole versus Mycophenolate mofetil therapy in children with frequently relapsing or steroid dependent nephrotic syndrome

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/015143
Enrollment
42
Registered
2018-07-31
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: N040- Nephrotic syndrome with minor glomerular abnormality

Interventions

Intervention1: Levamisole: 2.5 mg/kg/day for 1 year Control Intervention1: Mycophenolate mofetil: 1000 mg/sq.m for 1 year

Sponsors

Jawaharlal Nehru Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Two or more relapses in 6 months while on alternate day levamisole with tapering alternate day prednisolone therapy, or 2. If the prednisolone threshold to maintain remission exceeds 0.7 mg/kg on alternate days or, 3. Patients have significant steroid toxicity (cushingoid with hypertension, ocular toxicity such as cataract, glaucoma or an episode of serious life threatening infection).

Exclusion criteria

Exclusion criteria: 1.Age at onset of nephrotic syndrome less than 1 year or more than 10 year. 2. History of use of alternative treatment other than alternate day levamisole. 3. Biopsy showing pathology other than MCNS. 4. Secondary nephrotic syndrome. 5. Late steroid resistance. 6. Residing >100 km from centre or unwilling to follow up.

Design outcomes

Primary

MeasureTime frame
Relapse frequencyTimepoint: At enrolment, 1 year

Secondary

MeasureTime frame
Side effects Time to first relapse Proportion of patients relapse-free Cumulative steroid dose used Failure of the trial medication in either groupTimepoint: During 1 year follow up period

Countries

India

Contacts

Public ContactJyotsana Singh

Jawaharlal Nehru Medical College

drkafzal@hotmail.com571-2721182

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 18, 2026