ERICONS

Early rituximab treatment in children with idiopathic nephrotic syndrome – ERICONS (Early Rituximab in Childhood Onset Nephrotic Syndrome)

recruitment completed Recruitment to the study has been completed – the planned patient population has been enrolled.

About the study

The ERICONS study evaluates the efficacy of early rituximab treatment in children with idiopathic nephrotic syndrome with a steroid-dependent or frequently relapsing course.

The aim of the project is to determine whether rituximab can extend the period of disease remission and reduce the need for long-term steroid treatment.

The study is multicentre and involves paediatric nephrology centres across Poland.

What is idiopathic nephrotic syndrome?

Idiopathic nephrotic syndrome is one of the most common kidney diseases in children. It is characterised by increased loss of protein in the urine, which may lead to swelling, disturbances in protein balance and an increased risk of infection.

In many cases, the disease has a relapsing course and requires repeated treatment cycles.

Some patients develop steroid-dependent nephrotic syndrome or frequently relapsing nephrotic syndrome, meaning that repeated steroid treatment is needed to maintain disease remission.

Why is a new treatment needed?

Steroids are the mainstay of treatment for idiopathic nephrotic syndrome, but long-term use may be associated with many side effects, including growth impairment, osteoporosis, metabolic complications and an increased risk of infection.

For this reason, treatment strategies are being sought that can reduce exposure to steroids while maintaining long-term disease remission.

Why rituximab?

Rituximab is a monoclonal antibody used in the treatment of several immune-mediated diseases and some cancers.

It works by selectively removing B lymphocytes – immune system cells that may play an important role in the pathogenesis of nephrotic syndrome.

The ERICONS study evaluates whether early use of rituximab can prolong disease remission and reduce the number of relapses.

Study design

ERICONS is a phase III, multicentre, randomised, double-blind, placebo-controlled clinical trial.

The primary endpoint is relapse-free time from randomisation to the first relapse during the blinded phase, lasting up to 365 days.

This study design allows for an objective assessment of treatment efficacy.

Study population

The study included children aged from 24 months to 16 years with steroid-dependent nephrotic syndrome or frequently relapsing nephrotic syndrome.

Patients from across Poland were enrolled in nine specialised paediatric nephrology centres.

Eligibility criteria

Inclusion criteria

willingness to participate in the study and signed informed consent by the patient or legal guardians after receiving information about the study;
age above 2 years and below 16 years at the time of enrolment;
diagnosis of idiopathic steroid-dependent nephrotic syndrome or frequently relapsing nephrotic syndrome;
remission of nephrotic syndrome, defined as absent or trace protein in urine dipstick testing for 3 consecutive days;
commitment by patients of reproductive potential to use effective contraception during the study and for 12 months after completion of rituximab treatment.

Exclusion criteria

previous use of immunosuppressive medicines such as cyclophosphamide, cyclosporine A, tacrolimus, mycophenolate mofetil or levamisole;
diagnosis of steroid-resistant nephrotic syndrome, nephritic syndrome or secondary nephrotic syndrome;
history of severe infection, including tuberculosis, systemic fungal infection or HIV, HCV or HBV infection;
severe heart disease, including heart failure, myocardial infarction or severe cardiac arrhythmia;
poorly controlled arterial hypertension;
autoimmune disease, including IgA vasculitis or systemic lupus erythematosus;
current or previous malignancy;
history of organ transplantation;
allergy to methylprednisolone, paracetamol, cetirizine or cotrimoxazole;
previous treatment with monoclonal antibodies;
use of another investigational medicinal product within 6 months before enrolment or participation in another study at the time of eligibility assessment;
severe immunodeficiency;
pregnancy, breastfeeding or refusal to use pregnancy prevention methods in patients able to become pregnant;
active infection;
live vaccine administered within 4 weeks before enrolment;
clinically significant laboratory abnormalities;
abnormal kidney function;
hypersensitivity to the active substance, murine proteins or any excipient of the investigational medicinal product.

Final eligibility was assessed on the basis of the full study protocol and the investigator’s medical evaluation.

Participating centres

The ERICONS study was conducted in nine specialised paediatric nephrology centres in Poland.

Gdańsk

University Clinical Centre in Gdańsk

Department of Kidney Diseases and Hypertension in Children and Adolescents

Białystok

L. Zamenhof University Children’s Clinical Hospital in Białystok

Department of Paediatrics and Nephrology

Kraków

University Children’s Hospital in Kraków

Department of Paediatric Nephrology

Lublin

University Children’s Hospital in Lublin

Department of Paediatric Nephrology, Medical University of Lublin; Department of Paediatrics and Nephrology

Łódź

Polish Mother’s Memorial Hospital Research Institute in Łódź

Department of Paediatrics, Immunology and Nephrology

Poznań

Karol Jonscher Clinical Hospital, Poznań University of Medical Sciences

Department of Paediatric Nephrology and Hypertension

Warsaw

University Clinical Centre of the Medical University of Warsaw

Department of Paediatric Nephrology and Paediatrics

Wrocław

University Clinical Hospital in Wrocław

Department of Paediatric Nephrology

Zabrze

Independent Public Clinical Hospital No. 1 in Zabrze, Medical University of Silesia in Katowice

Department of Paediatric Nephrology with Dialysis Unit; Department and Clinic of Paediatrics, Faculty of Medical Sciences in Zabrze

Study status

Recruitment to the ERICONS study has been completed. The full planned patient population has been enrolled.

coordinator Aleksandra Żurowska, MD, PhD, Professor

tel. 58 349 28 50

e-mail nefped@gumed.edu.pl

Organisational information

The project is funded by the Polish state budget through the Medical Research Agency (MRA) under the funding call for non-commercial clinical trials (call number: ABM/2019/1).

Project number: 2019/ABM/01/00024.

Project duration: 01 July 2020 – 30 June 2026.

Key information

project number

2019/ABM/01/00024-00

funding

PLN 11,960,320

status

recruitment completed

study type

Phase III clinical trial

study coordinator

Aleksandra Żurowska, MD, PhD, Professor

funder

Medical Research Agency (MRA)

Contact