Prevention of relapses with Levamisole as adjuvant therapy to corticosteroids in children with first episode of idiopathic nephrotic syndrome.

Prevention of relapses with Levamisole as adjuvant therapy to corticosteroids in children with first episode of idiopathic nephrotic syndrome. - LEARNS

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55651

Enrollment

Registered

2017-12-06

Start date

2018-04-25

Completion date

Unknown

Last updated

2025-09-01

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

Conditions

idiopathic nephrotic syndrome

Interventions

Treatment group receives levamisole 2.5 mg/kg on alternate days, maximum of 150 mg per day (tablets of 5, 10, 25, and 50 mg). Start of study medication is at 4 weeks after the start of steroid treat

4 weeks, followed by - 60 mg/mm2/alternate days

8 weeks, followed by - 45 mg/mm2/alternate days

2 weeks, followed by - 30 mg/mm2/alternate days

2 weeks, followed by - 15 mg/mm2/alternate days

2 weeks.

Eligibility

Age

2 Years to 15 Years

Inclusion criteria

Inclusion criteria: Children (age 2-16 years) with a first episode of idiopathic nephrotic syndrome

Exclusion criteria

Exclusion criteria: Steroid-resistant nephrotic syndrome (no remission after 4 weeks of steroid treatment)

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the occurrence of a first relapse within 12 months after randomization. A relapse is defined as the recurrence of proteinuria (3+ urine dipstick or proteinuria> 200 mg/mmol creatinine) for 3 consecutive days.	—

Secondary

Measure	Time frame
Secondary endpoints: - Time to first relapse; - Relapse rate (number of relapses per person year) over 2-year period; - Cumulative steroid dosage up to 2 years; - Occurrence of adverse events and treatment discontinuation; - Proportion of frequent relapsers or steroid dependency over 2-year period; - Toxicity of levamisole: - Proportion of patients with elevated ASAT-/ALAT-levels, neutropenia (25 kg/m2, hypertension (p>90), and (fasting) hyperglycemia. - Days of school missing, outpatient visits and hospitalization days (macro-economic analysis); - Number of treatment interruptions.	—

Measure

Time frame

Secondary endpoints: - Time to first relapse; - Relapse rate (number of relapses per person year) over 2-year period; - Cumulative steroid dosage up to 2 years; - Occurrence of adverse events and treatment discontinuation; - Proportion of frequent relapsers or steroid dependency over 2-year period; - Toxicity of levamisole: - Proportion of patients with elevated ASAT-/ALAT-levels, neutropenia (25 kg/m2, hypertension (p>90), and (fasting) hyperglycemia. - Days of school missing, outpatient visits and hospitalization days (macro-economic analysis); - Number of treatment interruptions.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)