TerminatedPhase 2

Efficacy of Anti-CD20 Antibodies (Rituximab Biosimilar) in the Treatment of Childhood Steroid-dependent Nephrotic Syndrome

Stopped: due to unexpectedly high rate of relapse in the active comparator arm.

Italy30 participantsStarted 2019-07-01

Plain-language summary

Anti-CD20 monoclonal antibodies are emerging as the steroid-sparing therapy of choice for nephrotic syndrome. This Randomized Clinical Trial seeks to evaluate whether Rituximab biosimilar maintains drug-free disease remission in patientswith steroid-dependent nephrotic syndrome for 12-24 months and verify its superiority vs. mycophenolate mofetil, the reference standard therapy. The investigators will compare the risk of relapse to test this hypothesis (primary outcome). Secondary objectives will include assessing short- and long-term side-effects and developing specific biomarkers of sensitivity to therapy. Patients will be recruited, treated and followed at IRCCS G Gaslini and IRCCS Bambino Gesù where laboratory studies will be performed at in-site facilities

Who can participate

Age range3 Years – 24 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: To be eligible for inclusion into this study, participants will have to fulfil the following criteria: * Age between 3 and 24 years * Prednison dependent steroid syndrome 0.3-1mg/Kg/day and receive prednisone for at least six months before enrolment. Steroid dependence is defined by two consecutive relapse during corticosteroid therapy or within 14 days of ceasing therapy. * Ability to provide consent and assent: parents'/guardian's written informed consent, and child's assent given before any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject any time without prejudice to his or her future medical care. Exclusion Criteria: Children will be excluded if any of the following criteria apply: * Positivity to autoimmunity tests (ANA, nDNA, ANCA) * Reduction of C3 levels. * eGFR\<90/ml/min/1,73 m2 valuated according to revised Bedside Schwartz Formula for patients between 2 and 17 years and with CKD-EPI Creatinine 2009 Equation for 18 years old patients. * Pregnancy * Neoplasm * Infections: previous or actual HBV (with HBeAb positivity) or HCV infection * CD20 B lymphocytes count \<2,5% * Treatment with Rituximab or cyclophosphamide in the last 6 months

What they're measuring

Comparison between RTX and MMF, considering number of partecipants and relative relapses in the two cohorts

Timeframe: 12-24 months

Trial details

NCT IDNCT04402580

SponsorIstituto Giannina Gaslini

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08-31