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

Conditions

steroid sensitive idiopathic nephrotic syndrome

Brief summary

The occurrence of relapses within 12 months after first presentation. A relapse is defined as the recurrence of proteinuria (3+ urine dipstick or proteinuria> 200 mg/mmol creatinine) for 3 consecutive days

Detailed description

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 (>3 times upper limit of normal), neutropenia (<1500/mm3) or positive ANCA., Toxicity of corticosteroids: Differences in BMI, blood pressure, height, weight, serum glucose between groups; Proportion of patients with overweight (BMI >25 kg/m2, hypertension (p>90), and hyperglycemia, Days of school missing, outpatient visits and hospitalization days (macro-economic analysis), Number of treatment interruptions

Related papers

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Interventions

DRUGELMISOL 5

DRUGELMISOL 25

DRUGELMISOL 50

DRUGELMISOL 10

DRUGthe placebo has the same composition as the tested IMP with the exception of the active substance

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The occurrence of relapses within 12 months after first presentation. 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
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 (>3 times upper limit of normal), neutropenia (<1500/mm3) or positive ANCA., Toxicity of corticosteroids: Differences in BMI, blood pressure, height, weight, serum glucose between groups; Proportion of patients with overweight (BMI >25 kg/m2, hypertension (p>90), and hyperglycemia, Days of school missing, outpatient visits and hospitalization days (macro-economic analysis), Number of treatment interruptions	—

Measure

Time frame

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 (>3 times upper limit of normal), neutropenia (<1500/mm3) or positive ANCA., Toxicity of corticosteroids: Differences in BMI, blood pressure, height, weight, serum glucose between groups; Proportion of patients with overweight (BMI >25 kg/m2, hypertension (p>90), and 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