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A study to compare the efficacy in terms of preventing disease recurrence; and safety in terms of drug related side effects of Mycophenolate mofetil in comparison with Levamisole in children with difficult to treat nephrotic syndrome, a chronic protein loosing kidney disease.

Randomized controlled trial to compare the efficacy & safety of Mycophenolate mofetil vs. Levamisole in children with Frequent relapsing & Steroid dependent nephrotic syndrome

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/10/004107
Enrollment
120
Registered
2013-10-29
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

Interventions

Intervention1: Mycophenolate mofetil: Mycophenolate mofetil 1200 mg/m2 per day along with tapering doses of alternate day prednisolone, during a 12 month period. Control Intervention1: levamisole: Lev

Sponsors

Nilratan Sircar Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children between 2years and16 years with FRNS with or without steroid dependency. Estimated glomerular filtration rate (eGFR) >80 ml/min per 1.73 m2. Children in remission at study entry (trace or nil proteinuria, as determined by the dipstick test or No previous use of any steroid sparing agent. Informed cosent.

Exclusion criteria

Exclusion criteria: Patients with severe leucopenia (leucocytes less than 3.0Ã? 1000 cells/mm3), severe anemia (haemoglobin less than 8.9 g/dl) or any active infection.

Design outcomes

Primary

MeasureTime frame
Frequency of relapsesTimepoint: number of relapses at 3,6,9 and 12 month.

Secondary

MeasureTime frame
1. Time to first relapse on steroid sparing treatment(mo) 2. Cumulative steroid dose (mg/kg/yr) 3. Sustained remission 4. Treatment Failure 5. No. of children off steroid at 12 mo. Timepoint: During 12 months period

Countries

India

Contacts

Public ContactBiswanath Basu

NRS Medical College and Hospital

basuv3000@gmail.com91-33-23453245

Outcome results

None listed

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