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

Phase 3

Recruiting

• Conditions: NEPHROTIC SYNDROME

• Registration Number: 2024-515058-26-00
• Lead Sponsor: Medical University Of Gdansk

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-11-07
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. 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 2. Age at study entry> 2 years (> 24 months of age) and under 16 years of age 3. 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) 4. 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 5. 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

Exclusion Criteria

1. Previous use of immunosuppressants such as cyclophosphamide, cyclosporin A, tacrolimus, mycophenolate mofetil, levamisole 2. Diagnosis of steroid-resistant NS, nephritic syndrome or secondary NS 3. Previous severe infection (tuberculosis, systemic mycosis), HIV, HCV, HBV infection 4. Active infection 5. Severe heart diseases (heart failure, myocardial infarction, severe heart rhythm disturbances) 6. Vaccinations with live vaccines within 4 weeks prior to study inclusion 7. Poorly controlled hypertension 8. Abnormal kidney function (eGFR <90 ml / min) 9. Autoimmune disease (IgA vasculitis, systemic lupus) 10. Current or history of cancer 11. Status after organ transplantation 12. Allergy to methylprednisolone, paracetamol, cetirizine, co-trimoxazole 13. Laboratory abnormalities: leukocyte count <3000 / µl, neutrocyte count <1500 / µl, platelet count <75,000 / µl, severe liver dysfunction: ALT or AST 2.5 times upper limit of normal 14. Prior treatment with monoclonal antibodies 15. Use of another study drug within the 6 months prior to study entry, or participation in other studies at screening 16. Severe immunodeficiency 17. Pregnancy, breastfeeding or refusal to use methods of contraception in case of the ability to become pregnant (pregnancy test required - beta hCG in the blood serum at enrollment in the study) 18. Hypersensitivity to the active substance, mouse proteins, or any of the excipients of the study drug (i.e. sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections)

Study & Design

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Medical University Of Gdansk; 🇵🇱 Gdansk, Poland

Polsko-Amerykański Instytut Pediatrii Collegium Medicum Uniwersytetu Jagiellońskiego w Krakowie; 🇵🇱 Kraków, Poland

Uniwersytet Medyczny w Poznaniu; 🇵🇱 Poznań, Poland

Uniwersytecki Szpital Dzieciecy W Lublinie; 🇵🇱 Lublin, Poland

Warszawski Uniwersytet Medyczny; 🇵🇱 Warszawa, Poland

Samodzielny Publiczny Szpital Kliniczny nr 1 w Zabrzu; 🇵🇱 Zabrze, Poland

Medical University Of Bialystok; 🇵🇱 Bialystok, Poland

Uniwersytet Medyczny we Wrocławiu; 🇵🇱 Wrocław, Poland

Instytut Centrum Zdrowia Matki Polki; 🇵🇱 Lodz, Poland

Medical University Of Gdansk

🇵🇱Gdansk, Poland

Aleksandra Żurowska

Site contact

+48583492850

nefped@gumed.edu.pl