BridgeMD
Prevention of the return of nephrotic syndrom in children by adding levamisole to prednisolone treatment
EU CTIS ID: 2024-517467-23-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility criteria
- 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
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.