Early rituximab treatment in children with idiopathic nephrotic syndrome Eng. ERICONS - Early RITUXIMAB in Childhood Onset Nephrotic Syndrome

Medical University Of Gdansk9 sites in 1 country60 target enrollmentNovember 7, 2024

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Medical University Of Gdansk
Enrollment: 60
Locations: 9
Primary Endpoint: Relapse-free survival (defined as the occurrence of proteinuria persisting for ≥ 3 days during the blinded phase (from day 1 to day 365)).
Status: Recruiting
Last Updated: last year

Assessment of the duration of disease remission in the study group compared to placebo

Registry

euclinicaltrials.eu

Start Date

November 7, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sponsor

Responsible Party

Principal Investigator

Chief Medical Officer; Principal Investigator

Scientific

Medical University Of Gdansk

•Expresses the willingness to participate in the study and after obtaining information about the study, the patient / legal guardians will sign an informed consent form for participation in the study
•Age at study entry> 2 years (> 24 months of age) and under 16 years of age
•Meet the criteria for diagnosis of idiopathic steroid-dependent nephrotic syndrome (two relapses during steroid dose reduction or within two weeks of stopping steroid therapy) or nephrotic syndrome with frequent relapses (two or more relapses in 6 months on steroid therapy or four or more relapses in a period of 12 months)
•Remission of NS immediately prior to study entry, defined as the absence or trace of protein in the urinalysis [uPCR <0.2 mg protein / mg creatinine (<20 mg protein / mmol creatinine) or <1+ in the test strip] for 3 consecutive days
•Patients of childbearing age (conception) will commit to abstinence or to use effective contraception during the study period and up to 12 months after stopping RTX treatment; girls of childbearing potential will have a negative pregnancy test on qualifying for treatment initiation

•Previous use of immunosuppressants such as cyclophosphamide, cyclosporin A, tacrolimus, mycophenolate mofetil, levamisole
•Diagnosis of steroid-resistant NS, nephritic syndrome or secondary NS
•Previous severe infection (tuberculosis, systemic mycosis), HIV, HCV, HBV infection
•Active infection
•Severe heart diseases (heart failure, myocardial infarction, severe heart rhythm disturbances)
•Vaccinations with live vaccines within 4 weeks prior to study inclusion
•Poorly controlled hypertension
•Abnormal kidney function (eGFR <90 ml / min)
•Autoimmune disease (IgA vasculitis, systemic lupus)
•Current or history of cancer

Relapse-free survival (defined as the occurrence of proteinuria persisting for ≥ 3 days during the blinded phase (from day 1 to day 365)).

Time to treatment failure 1a. Percentage of failures in the experimental and placebo groups.
Total dose of administered steroids.
Time from depletion resolution to relapse.
Relapse-free survival during the open-label phase (from the day of investigational drug administration to day 365 of observation).