Rituximab for Idiopathic nephrotic syndrome | Steroid-dependent nephrotic syndrome | Frequently relapsing nephrotic syndrome

Inclusion criteria

• {"criterion_text":"- 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"}
• {"criterion_text":"- 2. Age at study entry> 2 years (> 24 months of age) and under 16 years of age"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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

• {"criterion_text":"- 1. Previous use of immunosuppressants such as cyclophosphamide, cyclosporin A, tacrolimus, mycophenolate mofetil, levamisole"}
• {"criterion_text":"- 2. Diagnosis of steroid-resistant NS, nephritic syndrome or secondary NS"}
• {"criterion_text":"- 3. Previous severe infection (tuberculosis, systemic mycosis), HIV, HCV, HBV infection"}
• {"criterion_text":"- 4. Active infection"}
• {"criterion_text":"- 5. Severe heart diseases (heart failure, myocardial infarction, severe heart rhythm disturbances)"}
• {"criterion_text":"- 6. Vaccinations with live vaccines within 4 weeks prior to study inclusion"}
• {"criterion_text":"- 7. Poorly controlled hypertension"}
• {"criterion_text":"- 8. Abnormal kidney function (eGFR <90 ml / min)"}
• {"criterion_text":"- 9. Autoimmune disease (IgA vasculitis, systemic lupus)"}
• {"criterion_text":"- 10. Current or history of cancer"}
• {"criterion_text":"- 11. Status after organ transplantation"}
• {"criterion_text":"- 12. Allergy to methylprednisolone, paracetamol, cetirizine, co-trimoxazole"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 14. Prior treatment with monoclonal antibodies"}
• {"criterion_text":"- 15. Use of another study drug within the 6 months prior to study entry, or participation in other studies at screening"}
• {"criterion_text":"- 16. Severe immunodeficiency"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- 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)"}

Primary endpoints

• {"endpoint_text":"- Relapse-free survival (defined as the occurrence of proteinuria persisting for ≥ 3 days during the blinded phase (from day 1 to day 365)).","definition_or_measurement_approach":"Relapse-free survival defined as occurrence of proteinuria persisting for ≥ 3 days during the blinded phase (from day 1 to day 365)."}

Secondary endpoints

• {"endpoint_text":"- Time to treatment failure 1a. Percentage of failures in the experimental and placebo groups.","definition_or_measurement_approach":"Time-to-event measure comparing treatment failure rates; percentage of failures in experimental vs placebo groups."}
• {"endpoint_text":"- Total dose of administered steroids.","definition_or_measurement_approach":"Cumulative steroid dose administered (total dose), measured in standard units (as recorded during treatment)."}
• {"endpoint_text":"- Time from depletion resolution to relapse.","definition_or_measurement_approach":"Time interval from B-cell depletion resolution to clinical relapse."}
• {"endpoint_text":"- Relapse-free survival during the open-label phase (from the day of investigational drug administration to day 365 of observation).","definition_or_measurement_approach":"Relapse-free survival measured from day of investigational drug administration to day 365 during the open-label phase."}

Poland

Earliest CTIS Part Ii Submission Date

04-10-2024

Latest Decision Or Authorization Date

14-11-2025

Processing Time Days

406

Number Of Sites

9

Number Of Participants

60

Primary sponsor

Full Name

Medical University Of Gdansk

Organisation Type

Educational Institution

Country Of Registered Address

Poland

Third parties

• {"country":"","full_name":"Medical Research Agency (Agencja Badań Medycznych)","duties_or_roles":"Monetary support","organisation_type":""}