Prevention of the return of nephrotic syndrom in children by adding levamisole to prednisolone treatment

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001025-41-BE

Enrollment

Registered

2019-04-16

Start date

2019-06-14

Completion date

Unknown

Last updated

2024-06-03

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

Conditions

steroid sensitive idiopathic nephrotic syndrome MedDRA version: 20.1 Level: PT Classification code 10029164 Term: Nephrotic syndrome System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Product Name: Levamisole 5 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: LEVAMISOLE HYDROCHLORIDE CAS Number: 16595-80-5 Concentration unit: mg/kg milligram(s)/kilogram Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria for biobanking/immunomics: - Children with first episode of INS aged between 2 and 16 years. - INS definition: Hypoalbuminaemia (albumin 200 mg/mmol creatinine); Complement C3 within normal range. - Negative pregnancy test - Written informed consent Inclusion criteria for RCT - Steroid-sensitive INS (Remission after 4 weeks of corticosteroid treatment) - Weight >9 kg - Ability to swallow a (placebo) tablet of 5 mg (successful swallowing test in children =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria for biobanking/immunomics: - Previous episodes of INS Exclusion criteria for RCT: - Steroid-resistant INS (persistent proteinuria at 4 weeks after start steroid treatment). - Previous or current malignancy, diabetes mellitus, current liver disease, or convulsions. - Hypersensitivity to levamisole or one of its substances (lactose)

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of additional levamisole in comparison with placebo from 4 weeks to 6 months after the start of the first episode of steroid-sensitive INS in children (age 2 – 16 years) on the occurrence of relapses within 12 months.;Secondary Objective: - To investigate HRQoL at different stages of treatment - To identify medical and personal factors related to HRQoL, psychosocial adaptation and parental distress. - To investigate the saliva/plasma concentration ratio of prednisolone and levamisole. - To determine PK/PD of levamisole and prednisolone. - To investigate the applicability of saliva for determination of the prednisolone and levamisole plasma concentrations - To establish the functional immune disorders in INS using full-blood stimulation before and after start of treatment and upon relapse. - To establish the phenotype changes and differences of genotype of the immune system. - To establish the stratification of patients at risk for recurrent disease and identify immunological pathways. - To provide insight in the mechanism of action of levamisole in the prevention of relapses - To investigate the consequences of INS in terms of days of missing school, outpatient visits, hospital admission and therapy costs;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: 12 months after first presentation with Idiopathic Nephrotic Syndrome	—

Measure

Time frame

Main Objective: To investigate the effect of additional levamisole in comparison with placebo from 4 weeks to 6 months after the start of the first episode of steroid-sensitive INS in children (age 2 – 16 years) on the occurrence of relapses within 12 months.;Secondary Objective: - To investigate HRQoL at different stages of treatment - To identify medical and personal factors related to HRQoL, psychosocial adaptation and parental distress. - To investigate the saliva/plasma concentration ratio of prednisolone and levamisole. - To determine PK/PD of levamisole and prednisolone. - To investigate the applicability of saliva for determination of the prednisolone and levamisole plasma concentrations - To establish the functional immune disorders in INS using full-blood stimulation before and after start of treatment and upon relapse. - To establish the phenotype changes and differences of genotype of the immune system. - To establish the stratification of patients at risk for recurrent disease and identify immunological pathways. - To provide insight in the mechanism of action of levamisole in the prevention of relapses - To investigate the consequences of INS in terms of days of missing school, outpatient visits, hospital admission and therapy costs;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: 12 months after first presentation with Idiopathic Nephrotic Syndrome

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Secondary

Measure	Time frame
Secondary end point(s): - 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 (25 kg/m2, hypertension (p>90), and hyperglycemia. - Days of school missing, outpatient visits and hospitalization days (macro-economic analysis); - Number of treatment interruptions. ;Timepoint(s) of evaluation of this end point: Secondary endpoints are analysed as - Time to first occurence - Number of relapses during 2-year follow-up period after first presentation of INS	—

Measure

Time frame

Secondary end point(s): - 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 (25 kg/m2, hypertension (p>90), and hyperglycemia. - Days of school missing, outpatient visits and hospitalization days (macro-economic analysis); - Number of treatment interruptions. ;Timepoint(s) of evaluation of this end point: Secondary endpoints are analysed as - Time to first occurence - Number of relapses during 2-year follow-up period after first presentation of INS

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Countries

Belgium, Netherlands

Contacts

Public ContactLEARNS Clinical Trial Team

Amsterdam University Medical Center, location AMC

learns@amc.uva.nl+3120566 8844

Outcome results

None listed

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