Levamisole treatment for children with steroid sensitive nephrotic syndrome. A multi-centre, double-blind, placebo-controlled, randomised trial. - Levamisol Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005745-18-BE

Enrollment

100

Registered

2007-09-10

Start date

2007-10-10

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

Steroid Sensitive Nephrotic Syndrome (SSNS) MedDRA version: 9.1 Level: LLT Classification code 10029172 Term: Nephrotic syndrome with unspecified pathological lesion in kidney

Interventions

Product Name: Levamisole Hydrochloride Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Levamisole Hydrochloride CAS Number: 14769734 Concentration unit: mg milligram(s) Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Frequently relapsing idiopathic SSNS with or without steroid dependency - Age between 2 and 18 years Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patient previously treated with Levamisole - Patients unresponsive to Cyclosporine or MMF - Nephrotic Syndrome due to specific kidney disease - Patients presenting with leucopenia, convulsions or with hepatic diseases

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of one year of alternate days Levamisole treatment in a dose of 2.5mg/kg in the prevention of relpases and prolonging the time to relapse after cessation of corticosteroids treatment in children with SNSS;Secondary Objective: - Evaluation whether the effect of Levamisole varies with disease status - Evaluation whether the effect of Levamisole varies with prior treatment with Cyclosphosphamide. - Assessment of steroid sparing effect of Levamisole treatment as well as the sparing effect of other immunosuppressive drugs - Determination whether the effectiveness of Levamisole remains constant or wanes over time - Assessment of pharmacokinetics of Levamisole in the target population - Assessment of the safety of treatment with Levamisole;Primary end point(s): Time to relapse	—

Measure

Time frame

Main Objective: To assess the efficacy of one year of alternate days Levamisole treatment in a dose of 2.5mg/kg in the prevention of relpases and prolonging the time to relapse after cessation of corticosteroids treatment in children with SNSS;Secondary Objective: - Evaluation whether the effect of Levamisole varies with disease status - Evaluation whether the effect of Levamisole varies with prior treatment with Cyclosphosphamide. - Assessment of steroid sparing effect of Levamisole treatment as well as the sparing effect of other immunosuppressive drugs - Determination whether the effectiveness of Levamisole remains constant or wanes over time - Assessment of pharmacokinetics of Levamisole in the target population - Assessment of the safety of treatment with Levamisole;Primary end point(s): Time to relapse

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Countries

Belgium, France

Outcome results

None listed

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