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

Phase 1

• Conditions: steroid sensitive idiopathic nephrotic syndrome; MedDRA version: 20.1Level: PTClassification code 10029164Term: Nephrotic syndromeSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-001025-41-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-06
• Last Update Posted: 26 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Inclusion criteria for biobanking/immunomics:
- Children with first episode of INS aged between 2 and 16 years.
- INS definition: Hypoalbuminaemia (albumin <25 g/L); Proteinuria (>200 mg/mmol creatinine); Complement C3 within normal range.
- 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 <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
Are the trial subjects under 18? yes
Number of subjects for this age range: 92
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified