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Active, not recruitingPhase 3

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

Key facts

Who runs it
Amsterdam UMC Stichting
Where
Netherlands13 sites in 1 countryChoose a country to see its sites
Status
Active, not recruiting
Phase
Phase 3
People taking part
87 people, planned
Started
29 Nov 2024
Expected to end
1 Mar 2027
Type of study
Interventional
Record updated
1 October 2026

Who can take part

Age
Up to 17 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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 <6 years)
  • Negative pregnancy test in girls that are of childbearing potential
  • Absence of contraindication for levamisole use: neutropenia <1500/mmP3
  • Written informed consent
  • Ability to comply with study protocol

Who cannot take part

  • 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)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Prevention of relapse with Levamisole as adjuvant therapy to corticosteroids in children with first episode of idiopathic nephrotic syndrome
Record updated
1 October 2026