ESPN 51th Annual Meeting

ESPN 2018


 
Prevention of relapses with levamisole as adjuvant therapy to corticosteroids in children with a first episode of idiopathic nephrotic syndrome – An international, double-blind, placebo-controlled randomized trial.
VELTKAMP FLOOR 1 REEFMAN CHRISTA 1 KHAN DJERA H 1 VEISSI SUSAN 2 HAVERMAN LOTTE 1 MATHôT RON AA 1 LEVTCHENKO ELENA 4 SCHREUDER MICHIEL F 2 VAN WIJK ANS AE 3 FLORQUIN SANDRINE 1 BOUTS ANTONIA HM 1

1- ACADEMIC MEDICAL CENTER
2- RADBOUD UNIVERSITY MEDICAL CENTER
3- VU MEDICAL CENTER
4- UNIVERSITY HOSPITALS LEUVEN
 
Introduction:

Introduction: Idiopathic nephrotic syndrome (INS) is a rare disease with an incidence of 60 newly diagnosed cases per year in the Netherlands.  Recent research has shown that adding levamisole to corticosteroids in patients with frequent relapses significantly reduces the number of relapses and improves the relapse-free survival rate. Levamisole is an anthelminthic drug with immunomodulatory effects. It has, compared to other steroid-sparing drugs, relatively few side effects. In children with a first episode of INS, adding levamisole to initial treatment has never been studied. 

Objectives: We hypothesize that adding levamisole to standard therapy with corticosteroids reduces the number of relapses in 12 months after first presentation of INS in children. Additionally, the cumulative steroid dose will be reduced, while the time to first relapse increases, and the quality of life improves.  

Material and methods:

 Methods: An international, double-blind, placebo-controlled randomized trial will be conducted in 20 participating hospitals in the Netherlands and Belgium. All patients, aged between 2 and 16 years, with a first episode of INS will be checked for eligibility. After remission with 4 weeks of oral steroid treatment, participants (n=92) will be randomly assigned in a 1:1 ratio to either levamisole (2.5 mg/kg on alternate days) or placebo added to prednisolone treatment (French schedule) for 24 weeks. The follow-up of patients will be until 2 years after first presentation. Additionally, quality of life-questionnaires will be filled out and extra blood will be collected to 1) establish a biobank, 2) to investigate the immunologic features of INS and levamisole, and 3) to assess the pharmacokinetics and pharmacodynamics of levamisole and a possible interaction with prednisolone. Also, the feasibility of measuring levamisole concentrations in saliva will be investigated.

Results:

Ethics: The study protocol was approved by the Medical Ethical Committee of the Academic Medical Center.

Conclusions: